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OBJECTIVE: To evaluate the safety and efficacy of the granisetron transdermal delivery system (GTDS) combined with Dexamethasone for preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving Capecitabine plus Oxaliplatin (CapeOX) therapy. DESIGN: Open-label, prospective, multi-center phase II trial. SETTING: Three institutions. PARTICIPANTS: Fifty-four patients scheduled to receive CapeOX chemotherapy. INTERVENTIONS: Participants received GTDS (3.1 mg applied to the upper arm 48 h before chemotherapy, replaced on day 5, and discarded on day 12) and Dexamethasone. MAIN OUTCOME MEASURES: The primary endpoint was the complete control rate of CINV. Secondary endpoints included the duration of delayed complete control, complete control rate in the acute phase, safety, and quality of life. RESULTS: The complete control rate for delayed CINV over the entire period (25-480 h) was 72.7% (95% CI 0.57-0.88). The duration of delayed complete control was 17.2 ± 4.5 days, with 51.5% of patients experiencing no nausea during the delayed phase. The complete control rate in the acute phase was 81.8% (95% CI 0.69-0.95). No serious adverse events related to the antiemetic regimen were reported. CONCLUSION: Prolonged administration of GTDS is safe and effective for preventing CINV in patients with gastrointestinal malignancies treated with CapeOX. TRIAL REGISTRATION: ClinicalTrials.gov registry (NCT05325190); registered on October 10, 2021.
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Administración Cutánea , Protocolos de Quimioterapia Combinada Antineoplásica , Capecitabina , Granisetrón , Náusea , Oxaliplatino , Vómitos , Humanos , Masculino , Femenino , Granisetrón/administración & dosificación , Granisetrón/uso terapéutico , Persona de Mediana Edad , Capecitabina/administración & dosificación , Capecitabina/efectos adversos , Oxaliplatino/administración & dosificación , Oxaliplatino/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Náusea/inducido químicamente , Náusea/prevención & control , Vómitos/inducido químicamente , Vómitos/prevención & control , Vómitos/tratamiento farmacológico , Anciano , Estudios Prospectivos , Adulto , Antieméticos/administración & dosificación , Antieméticos/uso terapéutico , Calidad de Vida , Dexametasona/administración & dosificación , Dexametasona/uso terapéuticoRESUMEN
BACKGROUND: Mirtazapine blocks 5-hydroxytryptamine type (5-HT)2A, 5-HT2C, 5-HT3 and histamine H1 receptors, similarly to olanzapine. This study aimed to investigate the efficacy and safety of mirtazapine plus granisetron and dexamethasone for carboplatin (CBDCA)-induced nausea and vomiting in patients with thoracic cancers. METHODS: We conducted a prospective, open-label, single-arm, multicenter, phase II trial in four institutions in Japan. Registered patients were moderately to highly emetogenic chemotherapy-naïve, and were scheduled to receive CBDCA at area under the curve (AUC) ≥ 4 mg/mL per minute. Patients received mirtazapine 15 mg/day orally at bedtime for four consecutive days, in combination with granisetron and dexamethasone. Primary endpoint was complete response (CR; no emesis and no use of rescue medication) rate during the delayed period (24-120 h). RESULTS: Between July 2022 and July 2023, 52 patients were enrolled, and 48 patients were evaluated. CR rates in the delayed (24-120 h), overall (0-120 h), and acute periods (0-24 h) were 83.3%, 83.3%, and 100%, respectively. No grade 3 or higher treatment-related adverse events were observed except for one patient who had grade 3 dry mouth as evaluated by Common Terminology Criteria for Adverse Events version 5.0. CONCLUSIONS: Prophylactic antiemetic therapy with mirtazapine plus granisetron and dexamethasone shows promising efficacy and an acceptable safety profile. This three-drug combination appears to be a reasonable treatment approach in patients with thoracic cancers receiving a CBDCA-based regimen at AUC ≥ 4 mg/mL per minute.
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Antieméticos , Carboplatino , Dexametasona , Granisetrón , Mirtazapina , Náusea , Vómitos , Humanos , Granisetrón/administración & dosificación , Granisetrón/uso terapéutico , Masculino , Mirtazapina/uso terapéutico , Mirtazapina/administración & dosificación , Femenino , Dexametasona/administración & dosificación , Dexametasona/uso terapéutico , Persona de Mediana Edad , Anciano , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Estudios Prospectivos , Carboplatino/efectos adversos , Carboplatino/administración & dosificación , Antieméticos/uso terapéutico , Antieméticos/administración & dosificación , Neoplasias Torácicas/tratamiento farmacológico , Neoplasias Torácicas/patología , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Anciano de 80 o más Años , Japón , Quimioterapia CombinadaRESUMEN
BACKGROUND: Recently, use of HT35 receptor antagonists to prevent postoperative shivering has attracted a great deal of attention. This study was conducted with the aim of investigating the effectiveness of granisetron as an HT35 antagonist when compared with ondansetron and meperidine in preventing postoperative shivering. MATERIAL AND METHODS: In this triple blind random clinical trial study, 90 patients 18-50 years of age with ASA Class I and II undergoing general anesthesia were randomly assigned into one of the three drug groups: O (4-mg ondansetron), G (40 µg/kg of granisetron), and P (25 mg meperidine), immediately before induction of anesthesia. After anesthesia induction, at the end of the surgery, after the entrance and after leaving the recovery state, central temperature, peripheral temperature, heart rate, systolic blood pressure, diastolic blood pressure, and shivering were measured and documented. Two-tailed P < 0.05 was considered significant. RESULTS: In the meperidine, ondansetron, and granisetron groups, 4 (13.3%), 3 (10%), and 10 (33.3%) of patients experienced shivering during recovery, where the difference between the ondansetron and granisetron groups was significant (p-value=0.02). The variations in the mean arterial pressure during the investigation stages only in the ondansetron group were not significant (p>0.05). At the beginning of recovery, the reduction of peripheral temperature significantly was lower in the ondansetron group (p<0.05), while reduction of the central temperature was significantly (p<0.05) higher in the granisetron group. By the end of the recovery, the variations in the peripheral temperature across the three groups were consistent with the changes at the beginning of recovery, but variations of the central temperature across the three groups was not significantly diverse. CONCLUSION: Granisetron was not found to be much effective in preventing postoperative shivering. Ondansetron and meperidine were equally effective in preventing postoperative shivering. Ondansetron also causes less hemodynamic changes compared to other drugs, while granisetron is more effective in terms of preventing nausea and vomiting.
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Granisetrón , Ondansetrón , Humanos , Granisetrón/uso terapéutico , Granisetrón/farmacología , Meperidina/uso terapéutico , Meperidina/farmacología , Ondansetrón/uso terapéutico , Ondansetrón/farmacología , Tiritona , Adulto Joven , Adulto , Persona de Mediana EdadRESUMEN
BACKGROUND: Automatic monitoring and assessment are increasingly employed in drug safety evaluations using hospital information system data. The increasing concern about granisetron-related arrhythmias requires real-world studies to improve our understanding of its safety. AIM: This study aimed to analyze the incidence, clinical characteristics, and risk factors of granisetron-related arrhythmias in hospitalized patients using real-world data obtained from the Adverse Drug Event Active Surveillance and Assessment System-II (ADE-ASAS-II) and concurrently aimed to develop and validate a nomogram to predict the occurrence of arrhythmias. METHOD: Retrospective automatic monitoring of inpatients using granisetron was conducted in a Chinese hospital from January 1, 2017, to December 31, 2021, to determine the incidence of arrhythmias using ADE-ASAS- II. Propensity score matching was used to balance confounders and analyze clinical characteristics. Based on risk factors identified through logistic regression analysis, a prediction nomogram was established and internally validated using the Bootstrap method. RESULTS: Arrhythmias occurred in 178 of 72,508 cases taking granisetron with an incidence of 0.3%. Independent risk factors for granisetron-related arrhythmias included medication duration, comorbid cardiovascular disease, concomitant use of other 5-hydroxytryptamine 3 receptor antagonists, alanine aminotransferase > 40 U/L, and blood urea nitrogen > 7.5 mmol/L. The nomogram demonstrated good differentiation and calibration, with enhanced clinical benefit observed when the risk threshold ranged from 0.10 to 0.82. CONCLUSION: The nomogram, based on the five identified independent risk factors, may be valuable in predicting the risk of granisetron-related arrhythmias in the administered population, offering significant clinical applications.
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Arritmias Cardíacas , Granisetrón , Nomogramas , Humanos , Granisetrón/efectos adversos , Femenino , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Arritmias Cardíacas/inducido químicamente , Arritmias Cardíacas/epidemiología , Anciano , Estudios de Casos y Controles , Factores de Riesgo , Incidencia , Adulto , China/epidemiología , Antieméticos/efectos adversos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Anciano de 80 o más AñosRESUMEN
PURPOSE: The effects of the 5-hydroxytryptamine (5-HT3) receptor antagonists on regional anaesthesia are complex and unclear. The present study was designed to test the hypothesis that granisetron, a selective 5-HT3 receptor antagonist, would decrease the duration of motor block, sensory block, and proprioception in a dose-dependent fashion in a rat model of bupivacaine-induced sciatic nerve blockade. MATERIALS AND METHODS: Thirty-eight male Wistar Albino rats that received unilateral sciatic nerve blocks were randomly divided into five experimental groups. Group B received a perineural of 0.3 ml of bupivacaine alone; Group BG800 received perineural 0.3 ml of bupivacaine and 800 µg of granisetron 10 min later; Group BG1200 received perineural 0.3 ml of bupivacaine and 1200 µg of granisetron 10 min later; Group BG1200IP received a perineural 0.3 ml of bupivacaine and an intraperitoneal injection of 1200 µg of granisetron 10 min later; and Group S was sham operated. A blinded investigator assessed motor, sensory and proprioception function every 10 min until the return of normal function. RESULTS: The medians for recovery times in Group B, Group BG800, Group BG1200, and Group BG1200IP were 105, 64, 85, and 120 min for motor function, respectively; 80, 64, 84, and 104 min for sensory function; 80, 63, 85, and 108 min were calculated for the proprioception function. The time to the return of normal motor, sensory, and proprioception function was not statistically significantly different between the groups (p > 0.05). Motor block did not develop in any of the rats in Group S. CONCLUSIONS: Local and systemic application of granisetron was not significantly decrease the duration of bupivacaine induced motor, sensory, and proprioception block of sciatic nerve in rat.
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Anestesia de Conducción , Bloqueo Nervioso , Ratas , Masculino , Animales , Bupivacaína/farmacología , Anestésicos Locales/farmacología , Granisetrón/farmacología , Ratas Wistar , Nervio CiáticoRESUMEN
General anxiety disorders are among the most prevalent mental health problems worldwide. The emergence and development of anxiety disorders can be due to genetic (30-50%) or non-genetic (50-70%) factors. Despite medical progress, available pharmacotherapies are sometimes ineffective or can cause undesirable side effects. Thus, it becomes necessary to discover new safe and effective drugs against anxiety. This study evaluated the anxiolytic effect in adult zebrafish (Danio rerio) of a natural pyrroloformamide (PFD), N-(4,5-dihydro-5-oxo-1,2-dithiolo-[4,3,b]-pyrrole-6-yl)-N-methylformamide, isolated from a Streptomyces sp. bacterium strain recovered from the ascidian Eudistoma vannamei. The complete structure of PFD was determined by a detailed NMR analysis, including 1H-13C and 1H-15N-HBMC data. In addition, conformational and DFT computational studies also were performed. A group of fishes (n = 6) was treated orally with PFD (0.1, 0.5 and 1.0 mg/mL; 20 µL) and subjected to locomotor activity and light/dark tests, as well as, acute toxicity 96 h. The involvement of the GABAergic and serotonergic (5-HT) systems was investigated using flumazenil (a silent modulator of GABA receptor) and 5-HT1, 5-HT2A/2C and 5-HTR3A/3B receptors antagonists, known as pizotifen, granisetron and cyproheptadine, respectively. PFD was nontoxic, reduced locomotor activity and promoted the anxiolytic effect in zebrafish. Flumazenil did not inhibit the anxiolytic effect of the PFD via the GABAergic system. This effect was reduced by a pretreatment with pizotifen and granisetron, and was not reversed after treatment with cyproheptadine. Molecular docking and dynamics studies confirmed the interaction of PFD with the 5-HT receptor.Communicated by Ramaswamy H. Sarma.
Pyrroloformamide (PFD), isolated from the marine Streptomyces sp. associated ascidian Eudistoma vannamei, showed no toxicity in adult zebrafish but reduced its locomotor activity.The structural elucidation of PFD was determined by the analysis of 1D and 2D NMR and HRESIMS data.The density functional theory (DFT) study confirmed the existence of two conformers as determined by NMR spectra.The serotonergic system modulated the anxiolytic effect of PFD via the 5-HT receptor in adult zebrafish.Molecular docking and dynamics studies confirmed the interaction of PFD with the 5-HT receptor.
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Ansiolíticos , Animales , Ansiolíticos/farmacología , Ansiolíticos/uso terapéutico , Pez Cebra , Serotonina , Flumazenil/farmacología , Pizotilina , Simulación del Acoplamiento Molecular , Granisetrón , CiproheptadinaRESUMEN
Postoperative shivering is one of the most common complications of surgeries. The current research compared the effects of ketamine, granisetron, and dexmedetomidine on reducing postoperative shivering after general anesthesia. This double-blind clinical trial enrolled 148 patients (39.08 ± 5.99 years old) who had been admitted to Vali-Asr Hospital of Arak, Iran in 2019-2021. The study drugs, including dexmedetomidine, ketamine, granisetron and normal saline, were administered in corresponding groups 30 minutes before the end of surgery. The results showed that dexmedetomidine reduced mean arterial pressure and heart rate in patients. The lowest incidence of shivering was observed in the dexmedetomidine group and it increased the duration of recovery. Overall, dexmedetomidine is recommended to reduce postoperative shivering after general anesthesia, but the increase in duration of recovery should be considered.
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Dexmedetomidina , Ketamina , Humanos , Adulto , Persona de Mediana Edad , Granisetrón/uso terapéutico , Granisetrón/farmacología , Ketamina/farmacología , Ketamina/uso terapéutico , Dexmedetomidina/farmacología , Dexmedetomidina/uso terapéutico , Tiritona , Hemodinámica , Anestesia General/efectos adversosRESUMEN
OBJECTIVES: Observational studies have reported associations between dried fruit intake and DNA methylation(DNAm). However, inherent flaws in observational study designs make them susceptible to confounding and reverse causality bias. Consequently, it is unclear whether a causal association exists. In the present study, we aimed to investigate the causal associations between dried fruit intake and DNAm. METHODS: We performed two-sample Mendelian randomization (MR) using the IEU Open GWAS database aggregated data. Forty-three single nucleotide polymorphisms (SNPs) associated with dried fruit intake as instrumental variables (IVs) were selected as exposure. DNAm outcomes include Gran (estimated granulocyte proportions); AgeAccelGrim(GrimAge acceleration); Hannum (Hannum age acceleration); IEAA(Intrinsic epigenetic age acceleration), AgeAccelPheno( PhenoAge acceleration), and DNAmPAIadjAge (DNAm-estimated plasminogen activator inhibitor-1 levels). We used the MR pleiotropy residual sum and outlier test (MRPRESSO) and Radial-MR test to identify any level of multi-effect outliers and assessed the causal effect estimates(after removing outliers). The primary causal effects were estimated using inverse-variance weighted (IVW) method and undertook sensitivity analyses using MR methods robust to horizontal pleiotropy.The direct effects of dried fruit intake on DNAm were estimated using multivariable mendelian randomization (MVMR). RESULTS: Leveraging two-sample MR analysis, we observed statistically significant associations between dried fruit intake with a lower AgeAccelGrim(ß=-1.365, 95% confidence intervals [CI] -2.266 to -0.464, PIVW=2.985×10-3) and AgeAccelPheno (ß= -1.933, 95% CI -3.068 to -0.798, PIVW=8.371×10-4). By contrast, the effects level on Gran (ß=0.008, PIVW=0.430), Hannum(ß=-0.430, PIVW=0.357), IEAA(ß=-0.184, PIVW=0.700), and DNAmPAIadjAge (ß=-1.861, PIVW=0.093) were not statistically significant. MVMR results adjusting for the potential effects of confounders showed that the causal relationship between dried fruit intake and AgeAccelGrim(ß= -1.315, 95% CI -2.373 to -0.258, PIVW=1.480×10-2) and AgeAccelPheno(ß= -1.595, 95% CI -2.987 to -0.202, PIVW=2.483×10-2) persisted. No significant horizontal polymorphism was found in the sensitivity analysis. CONCLUSION: Our MR study suggested that increased dried fruit intake is associated with slower AgeAccelGrim and AgeAccelPheno. It can providing a promising avenue for exploring the beneficial effects of dried fruit intake on lifespan extension.
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Metilación de ADN , Frutas , Humanos , Bases de Datos Factuales , Frutas/genética , Granisetrón , Análisis de la Aleatorización Mendeliana , Polimorfismo de Nucleótido SimpleRESUMEN
Introduction. Medical device colonization by pathogenic microorganisms is a risk factor for increasing infections associated with health care and, consequently, the morbidity and mortality of intubated patients. In Colombia, fungal colonization of endotracheal tubes has not been described, and this information could lead to new therapeutic options for the benefit of patients. Objective. To describe the colonizing fungi of the endotracheal tubes from patients in the intensive care unit, along with its antifungal sensitivity profile. Materials and methods. We conducted a descriptive, observational study in two health centers for 12 months. Endotracheal tubes were collected from patients in intensive care units. Samples were processed for culture, fungi identification, and antifungal sensitivity profile assessment. Results. A total of 121 endotracheal tubes, obtained from 113 patients, were analyzed: 41.32 % of the tubes were colonized by Candida albicans (64.62%), C. nonalbicans (30.77%), Cryptococcus spp. (3.08%) or molds (1.54%). All fungi evaluated showed a high sensitivity to antifungals, with a mean of 91%. Conclusion. Fungal colonization was found in the endotracheal tubes of patients under invasive mechanical ventilation. The antifungal sensitivity profile in these patients was favorable. A clinical study is required to find possible correlations between the colonizing microorganisms and infectivity.
Introducción. La colonización por microorganismos patógenos de los dispositivos médicos usados en las unidades de cuidados intensivos es un factor de riesgo para el aumento de infecciones asociadas con la atención en salud y, por lo tanto, al de la morbilidad y la mortalidad de los pacientes intubados. En Colombia, no se ha descrito la colonización por hongos de los tubos endotraqueales, con lo cual se podrían considerar nuevas opciones terapéuticas para el beneficio de los pacientes. Objetivo. Describir los hongos que colonizan los tubos endotraqueales de los pacientes en unidades de cuidados intensivos, junto con su perfil de sensibilidad a los antifúngicos. Materiales y métodos. Se realizó un estudio observacional, descriptivo, en dos centros hospitalarios durante 12 meses. Se recolectaron tubos endotraqueales de pacientes de las unidades de cuidados intensivos. Estos fueron procesados para cultivar e identificar hongos, y para establecer su perfil de sensibilidad a los antifúngicos. Resultados. Se analizaron 121 tubos endotraqueales obtenidos de 113 pacientes. De estos, el 41,32 % se encontró colonizado por los hongos Candida albicans (64,61 %), C. no-albicans (30,77 %), Cryptococcus spp. (3,08 %) o mohos (1,54 %). Todos los hongos evaluados presentaron una gran sensibilidad a los antifúngicos, con un promedio del 91 %. Conclusión. Se encontró colonización fúngica en los tubos endotraqueales de pacientes con asistencia respiratoria mecánica. El perfil de sensibilidad en estos pacientes fue favorable. Se requiere un estudio clínico para correlacionar los microorganismos colonizadores y su capacidad de generar infección.
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Candida albicans , Granisetrón , Colombia , TolnaftatoRESUMEN
Objectives: This study aimed to reduce the intensity of myoclonus movements by comparing the effectiveness of granisetron and sufentanil in reducing the intensity of etomidate-induced myoclonic movements. Etomidate-induced myoclonus occurs in up to 85% of patients under general anaesthesia. This type of myoclonus can induce significant clinical and economic problems in patients with special conditions. Methods: This double-blind randomised clinical trial study consisted of 96 adult patients recruited between January and July 2021 from Mashhad University of Medical Sciences, Mashhad, Iran. Using block randomisation, subjects were divided into three groups of 32 patients: the group receiving granisetron 40 µg/kg (group G), the group receiving sufentanil 0.2 µg/kg (group S) and the control group who did not receive the pretreatment (group C). Patients received these medications as pretreatments 120 seconds before induction with etomidate. After the injection of etomidate with a dose of 0.3 mg/kg, the incidence of myoclonus was evaluated. After evaluating the myoclonus, the full dose of narcotics (fentanyl 1 µg/kg) and muscle relaxants (atracurium 0.5 mg/kg) were administered to patients and a suitable airway was established for them. Results: The findings indicated that granisetron reduced the intensity and incidence of myoclonic movements more than sufentanil. In addition, myoclonic movements were observed at a significantly higher intensity in the control group (P = 0.001). Conclusion: The results obtained from the current study indicate that granisetron and sufentanil as pretreatments are effective for reducing myoclonus in patients.
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Etomidato , Mioclonía , Adulto , Humanos , Sufentanilo/efectos adversos , Etomidato/efectos adversos , Granisetrón , Mioclonía/inducido químicamente , Mioclonía/tratamiento farmacológico , Mioclonía/prevención & control , Anestesia GeneralRESUMEN
ABSTRACT Introduction: This study was performed to evaluate the degree of 3-day chemotherapy-induced nausea and vomiting (CINV) in children with cancer who received highly emetogenic chemotherapy (HEC) to ascertain the efficacy of aprepitant single-dose on dayL 1 plus granisetron and dexamethasone (DEX). Methods: This clinical trial study was conducted on 120 patients in the age range of 5 to 18 years old who received chemotherapy. Patients were divided into two groups; Group A received aprepitant at 125 mg/kg on day 1 orally, followed by 80 mg/kg daily on days 2 and 3 and Group B received a single dose of aprepitant 125 mg/kg on day 1 orally and placebo on days 2 and 3. All groups received granisetron 3 mg/m2 on day 1 and DEX on days 1 to 3. The primary and secondary endpoints were to evaluate the proportion of patients with acute, delayed and overall CINV within each group. Results: There were no significant differences between the two groups for vomiting, nausea or the use of rescue therapy. The number of patients without vomiting on day 1 was similar in both groups (96.5% vs. 98.3%, respectively; p = 0.848). Conclusion: According to the results of this study, a single dose of aprepitant 125 mg/kg was as effective as administering three doses of aprepitant on 3 days. Therefore, the use of a single dose of aprepitant in combination with other standard treatment regimens to prevent CINV in children who received HEC was safe and efficacious and can be beneficial.
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Humanos , Preescolar , Niño , Adolescente , Vómitos , Dexametasona , Granisetrón , Aprepitant , NáuseaRESUMEN
Serotonin 3 receptor antagonists, a commonly used drug for preventing postoperative nausea and vomiting, have recently been reported to decrease the incidence of hypotension and the need for vasoactive drugs after spinal anaesthesia in obstetric surgery. However, it remains unknown whether they could also prevent hypotension after induction of general anaesthesia. In the current study, we aimed to investigate the effect of intravenous granisetron on prophylactic ephedrine for preventing hypotension after general anaesthesia induction in elderly patients. Sixty elderly patients were randomly assigned to receive granisetron or saline control 30 min before induction of general anaesthesia. The first patient in each group received a prophylactic dose of ephedrine (0.15 mg kg-1) to prevent hypotension. The prophylactic dose for each patient was increased or decreased by 0.05 mg/kg based on the efficacy results of the previous patient. The up-down sequential allocation analysis and probit regression was used to calculate the effective dose for 50% of patients (ED50) with prophylactic ephedrine. In the up-down sequential allocation analysis, the ED50 of ephedrine was significantly lower in group granisetron (0.08 mg kg-1 [95% CI, 0.06-0.11 mg kg-1]) when compared with group control (0.14 mg kg-1 [95% CI, 0.13-0.16 mg kg-1]) (P < 0.001). The conclusion was further supported by probit regression analysis (0.09 mg kg-1 [95% CI, 0.05-0.12 mg kg-1] in group granisetron and 0.14 mg kg-1 [95% CI, 0.12-0.16 mg kg-1] in group control). Intravenous granisetron reduced the requirement of prophylactic ephedrine in preventing hypotension after general anaesthesia induction in elderly patients.
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Granisetrón , Hipotensión , Embarazo , Femenino , Humanos , Anciano , Granisetrón/uso terapéutico , Efedrina , Hipotensión/etiología , Náusea y Vómito Posoperatorios/prevención & control , Náusea y Vómito Posoperatorios/tratamiento farmacológico , Anestesia General/efectos adversos , Método Doble CiegoRESUMEN
BACKGROUND: Being overweight or obese is becoming increasingly prevalent worldwide and seriously endangers human health. Laparoscopic sleeve gastrectomy (LSG) has been successfully used for the treatment of severe obesity, but the incidence of postoperative nausea and vomiting (PONV) is high. However, traditional antiemetics have limited effects on PONV. Electropress needle therapy, which can be enhanced with electrical stimulation, is a promising therapy for the prevention and treatment of PONV. However, whether the electropress needle is effective for PONV in patients with LSG remains uncertain. METHODS: This was a prospective, randomized controlled trial. A total of 106 patients who planned to undergo elective LSG between October 2021 and July 2022 were randomly allocated to receive electropress needle stimulation combined with dexamethasone and granisetron (group A) or dexamethasone plus granisetron (group B). The primary outcome was the incidence of PONV 48 h after surgery. The secondary outcomes were PONV severity score, time to first flatus, length of hospital stay, visual analogue scale (VAS) score, and postoperative remedial medication use. RESULTS: Compared with dexamethasone plus granisetron, electropress needle stimulation combined with dexamethasone and granisetron significantly decreased the incidence and severity of PONV (P<0.001). Patients in Group A consumed less antiemetics postoperatively (P<0.05) and had a much shorter length of postoperative hospital stay (P<0.05). There was no difference in the time to first flatus between the two groups (P > 0.05). CONCLUSION: Electropress needle acupoint stimulation can reduce the incidence and severity of PONV in patients undergoing LSG.
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Antieméticos , Laparoscopía , Obesidad Mórbida , Humanos , Náusea y Vómito Posoperatorios/tratamiento farmacológico , Antieméticos/uso terapéutico , Granisetrón/uso terapéutico , Estudios Prospectivos , Flatulencia/tratamiento farmacológico , Laparoscopía/efectos adversos , Obesidad Mórbida/cirugía , Gastrectomía/efectos adversos , Obesidad/cirugía , Dexametasona/uso terapéutico , Método Doble CiegoRESUMEN
BACKGROUND: Many drugs are prescribed in relieving acute migraine attacks, we aim to compare metoclopramide with other antimigraine drugs. METHODS: We searched online databases like PubMed, Cochrane Library, Scopus, and Web of Science till June 2022 for RCTs that compared metoclopramide alone with placebo or active drugs. The main outcomes were the mean change in headache score and complete headache relief. The secondary outcomes were the rescue medications need, side effects, nausea and recurrence rate. We qualitatively reviewed the outcomes. Then, we performed the network meta-analyses (NMAs) when it was possible. which were done by the Frequentist method using the MetaInsight online software. RESULTS: Sixteen studies were included with a total of 1934 patients: 826 received metoclopramide, 302 received placebo, and 806 received other active drugs. Metoclopramide was effective in reducing headache outcomes even for 24 h. The intravenous route was the most chosen route in the included studies and showed significant positive results regarding headache outcomes; however, the best route whether intramuscular, intravenous, or suppository was not compared in the previous studies. Also, both 10 and 20 mg doses of metoclopramide were effective in improving headache outcomes; however, there was no direct comparison between both doses and the 10 mg dose was the most frequently used dosage. In NMA of headache change after 30 min or 1 h, metoclopramide effect came after granisetron, ketorolac, chlorpromazine, and Dexketoprofen trometamol. Only granisetron's effect was significantly higher than metoclopramide's effect which was only significantly higher than placebo and sumatriptan. In headache-free symptoms, only prochlorperazine was non-significantly higher than metoclopramide which was higher than other medications and showed significantly higher effects only with placebo. In rescue medication, metoclopramide's effect was only non-significantly lower than prochlorperazine and chlorpromazine while its effect was higher than other drugs and showed higher significant effects only than placebo and valproate. In the recurrence rate, studies showed no significant difference between metoclopramide and other drugs. Metoclopramide significantly decreased nausea more than the placebo. Regarding side effects, metoclopramide showed a lower incidence of mild side effects than pethidine and chlorpromazine and showed a higher incidence of mild side effects than placebo, dexamethasone, and ketorolac. The reported extrapyramidal symptoms with metoclopramide were dystonia or akathisia. CONCLUSION: A dose of 10 mg IV Metoclopramide was effective in relieving migraine attacks with minimal side effects. Compared to other active drugs, it only showed a lower significant effect compared with granisetron regarding headache change while it showed significantly higher effects only with placebo in both rescue medication needs and headache-free symptoms and valproate in only rescue medication need. Also, it significantly decreased headache scores more than placebo and sumatriptan. However, more studies are needed to support our results.
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Metoclopramida , Trastornos Migrañosos , Humanos , Metoclopramida/efectos adversos , Sumatriptán/uso terapéutico , Metaanálisis en Red , Proclorperazina/efectos adversos , Clorpromazina/uso terapéutico , Granisetrón/uso terapéutico , Ácido Valproico/uso terapéutico , Ketorolaco/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/complicaciones , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Cefalea/complicacionesRESUMEN
BACKGROUND: Chagas Disease (ChD) is a Neglected Tropical Disease (NTD) affecting 6 to 7 million people worldwide, mostly from Latin America. In Argentina, a national control program has been implemented since 1962, yet there are still an estimated 1.6 million infected individuals. Control programs were based almost exclusively on entomological surveillance and chemical control of households and were not continuous given a lack of coordination and resources. Argentina´s ChD program was originally vertical and centralized; later, it was partially and, in general, unsuccessfully transferred to the provinces. Herein, we describe the implementation of a control program for ChD with an ecohealth approach in rural settlements around the city of Añatuya, Santiago del Estero. METHODS: The program included yearly household visits for entomological surveillance and control, health promotion workshops, and structural house improvements. Improved structures included internal and external walls and roofs, as well as the construction of water wells and latrines, and the organization and improvement of peri-domestic structures. Activities were carried out by specifically trained personnel except for house improvements, which were performed by the community, under technical guidance and provision of materials. Data was collected using standardized questionnaires for household characterization, entomological infestation status and chemical control activities. RESULTS: This program was continuously implemented since 2005 with high community participation and adherence, incorporating 13 settlements and 502 households. During the surveillance phase, 4,193 domiciliary inspections were performed, and both the intra- and peri-domestic infestation rate were reduced from 17.9% to 0.2% (P < 0.01) and from 20.4% to 3%, respectively. Additionally, 399 households were structurally improved. CONCLUSION: The program is still ongoing and, after 14 years of implementation, has built social networks and collaboration between implementers and beneficiaries with a reduction of T. infestans infestation in the intra- and peri-domicile. This reduction, especially inside the household, has enabled access to diagnosis and treatment of the population, with minimal risk of re-infection.
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Enfermedad de Chagas , Humanos , Argentina/epidemiología , Enfermedad de Chagas/epidemiología , Enfermedad de Chagas/prevención & control , Participación de la Comunidad , Granisetrón , Promoción de la Salud , Enfermedades DesatendidasRESUMEN
BACKGROUND: In the fall of 2021, granisetron was approved for postoperative nausea and vomiting (PONV) management in Japan. However, the comparative efficacy of droperidol and granisetron in the field of orthognathic surgery has not been determined. PURPOSE: We compare the efficacy of droperidol and granisetron for PONV prophylaxis following orthognathic surgery. STUDY DESIGN, SETTING, SAMPLE: We performed a retrospective cohort study of patients who underwent orthognathic surgery at a single institution from September 2020 to December 2022. Patients who had undergone Le Fort I osteotomy with sagittal split ramus osteotomy or isolated sagittal split ramus osteotomy were included. Patients were divided into three groups; the isolated droperidol (D), isolated granisetron (G), and droperidol with granisetron (DG) groups. General anesthesia was performed using total intravenous anesthesia for all patients; however, droperidol and granisetron were administered at the anesthesiologist's discretion. PREDICTOR VARIABLE: PONV prophylactic therapy included isolated droperidol, isolated granisetron, and droperidol with granisetron administration. OUTCOME VARIABLES: Postoperative nausea (PON) and postoperative vomiting (POV) were determined through medical examination within 48 hours following surgery. Secondary outcomes included complications due to droperidol and/or granisetron administration. COVARIATES: Age, sex, body mass index, Apfel's score, duration of surgery, duration of anesthesia, intraoperative blood loss, and type of surgery. ANALYSES: Statistical analysis was conducted using Fisher exact test, Mann-Whitney U test with Bonferroni correction for univariate comparison, and modified Poisson regression for comparison of PON and POV prophylactic efficacy for multivariate analyses. P values <.05 were considered statistically significant. RESULTS: Our study included 218 participants. There were no significant differences in covariates between groups D (n = 111), G (n = 52), and DG (n = 55). No significant difference in PON incidence was observed between groups. However, POV incidence was significantly lower in group DG than group D (relative risk, 0.21; 95% confidence interval, 0.05 to 0.86; P = .03). No significant difference in complication incidence was observed between groups. CONCLUSIONS AND RELEVANCE: Granisetron was as effective as droperidol for PONV management, while droperidol combined with granisetron was more effective than isolated droperidol for POV management. As compared to the use of each drug separately, their combination was considered safe, with no increase in complication rates.
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Antieméticos , Cirugía Ortognática , Humanos , Droperidol/uso terapéutico , Granisetrón/uso terapéutico , Náusea y Vómito Posoperatorios/prevención & control , Estudios Retrospectivos , Antieméticos/uso terapéutico , Vómitos/tratamiento farmacológico , Vómitos/prevención & control , Método Doble CiegoRESUMEN
OBJECTIVES: The augmentation of serotonin reuptake inhibitors (SRIs) can be achieved by add-on therapy with different pharmacological agents in obsessive-compulsive disorder (OCD) for a better clinical outcome. This network meta-analysis (NMA) was conducted to evaluate and compare the effects of available augmentation agents for SRIs in OCD. METHOD: The data was extracted from 59 relevant clinical trials after a literature search on MEDLINE/PubMed, Scopus, Cochrane databases and clinical trial registries. PRISMA guidelines were followed in data extraction, analysis and reporting. Random effects Bayesian NMA was done to pool the effects across the interventions for the change in Yale-Brown Obsessive-Compulsive Scale (YBOCS) scoring from baseline to the end of the study. Network graph was built, consistency model was run, node splitting analysis was performed, treatments were ranked as per SUCRA score and meta-regression was done for refractoriness to SRIs and duration of augmentation therapy as the predictor variables. RESULTS: The drugs showing significant reduction in YBOCS scoring were pregabalin (MD:-8.1;95% CrI: -16, -0.43), memantine (MD:-6.2;95% CrI: -9.9, -2.3), lamotrigine (MD:-6;95% CrI: -12, -0.47), ondansetron (MD:-5.7;95% CrI: -11, -0.67), granisetron (MD:-5.6;95% CrI: -11, -0.44), aripiprazole (MD:-5.4;95% CrI:-9.1, -1.6), risperidone (MD:-3.3;95% CrI: -6.4, -0.20) and topiramate (MD:-5.3;95% CrI: -9.6, -0.97). The node-split analysis showed that direct and indirect pooled effect sizes for all comparisons were comparable. Meta-regression showed a statistically non-significant association between YBOCS score reduction with the duration of augmentation therapy, but significant with SRI-refractory status. Finally, the results were sorted based on certainty of evidence. CONCLUSION: Memantine was found to be most effective augmentation agent for SRIs in OCD, followed by lamotrigine, ondansetron and granisetron with moderate certainty of evidence. The augmentation agents showed better symptom reduction in patients with SRI-refractory OCD in comparison to non-refractory OCD. PROSPERO REGISTRATION: CRD42022360110.
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Trastorno Obsesivo Compulsivo , Inhibidores Selectivos de la Recaptación de Serotonina , Humanos , Inhibidores Selectivos de la Recaptación de Serotonina/farmacología , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Ondansetrón/uso terapéutico , Quimioterapia Combinada , Lamotrigina/uso terapéutico , Metaanálisis en Red , Teorema de Bayes , Granisetrón/uso terapéutico , Memantina/uso terapéutico , Trastorno Obsesivo Compulsivo/tratamiento farmacológico , Resultado del TratamientoRESUMEN
The authors sought to quantify the clinical impacts of granisetron, ketamine, dexmedetomidine, and lidocaine combined with fentanyl, for procedural sedation and analgesia in cystoscopy and for bladder catheter tolerance. This double-blind trial recruited four stratified blocked randomized eligible groups of patients (n = 120) formerly identified as needing cystoscopy, each receiving one of the above four anesthetic agents. Dexmedetomidine-sedated subjects experienced less pain from 5 to 120 minutes after the beginning of procedure, and next the ketamine manifested a better pain relief experienced. Sedation score was found to be rather more satisfactory in the early-mentioned from 15 to 55 minutes and at 90 and 105 minutes after procedure. The mean opioid use was observed lower in the dexmedetomidine treated patients and next in the ketamine administered patients. Considering the findings emanating from the study and the lack of complications that need to be treated, dexmedetomidine and ketamine afforded superior pain relief, greater sedation, and less postoperative opioid use in patients undergoing cystoscopy, and thus, they could be suggested to be combined with fentanyl during outpatient cystoscopy.
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Analgesia , Dexmedetomidina , Ketamina , Humanos , Fentanilo/farmacología , Fentanilo/uso terapéutico , Ketamina/farmacología , Ketamina/uso terapéutico , Dexmedetomidina/farmacología , Dexmedetomidina/uso terapéutico , Granisetrón , Lidocaína/farmacología , Lidocaína/uso terapéutico , Analgésicos Opioides/uso terapéutico , Cistoscopía , Vejiga Urinaria , Dolor/tratamiento farmacológico , Analgesia/métodos , CatéteresRESUMEN
The aim of this study was to evaluate postoperative analgesia effectiveness and patient-controlled analgesia (PCA)-related adverse events. The children who received sufentanil-based PCA following major surgery to repair congenital hip dislocation and hypospadias were divided into 3 groups: sufentanil 4 µg/kg + tramadol 10 mg/kg (ST; n = 301), sufentanil 4 µg/kg (S4; n = 211), and sufentanil 5 µg/kg (S5; n = 451). Analgesics with granisetron 0.2 mg/kg were diluted in 0.9% saline to 100 mL and infused continuously at a basal infusion rate of 1 mL/h. A total of 963 children whose average age was 4 years were investigated. The incidence of moderate to severe postoperative pain during rest was significantly lower in the S5 group (0.2%) and ST group (0.3%) compared with the S4 group (3.3%) within 72 hours after surgery (P < .05), and the incidence of moderate to severe pain during activity within 72 hours was also significantly lower in the S5 group (3.5%) compared with the other 2 groups (ST, 21.9%; S4, 33.2%; P < .001). A significant difference was identified among the 3 groups in the total number of PCA administrations, but there was no statistical difference of total usage of opioids among the 3 groups. In terms of PCA-related adverse events, the incidence of postoperative nausea and vomiting in the S5 group was lower compared with the ST group within 72 hours after surgery (P < .001), and there was no significant difference compared with the S4 group (P = .254). There was also no significant difference in the incidence of pruritus and dizziness among the 3 groups. Sufentanil-based PCA can be effectively and safely used in children after major congenital structural malformation repair surgeries. The sufentanil 5 µg/kg dosage in the PCA regimen is superior to sufentanil 4 µg/kg alone or combined with tramadol in lowering moderate to severe pain.
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Sufentanilo , Tramadol , Masculino , Humanos , Niño , Preescolar , Sufentanilo/efectos adversos , Analgesia Controlada por el Paciente/efectos adversos , Incidencia , Analgésicos Opioides/efectos adversos , Dolor Postoperatorio/tratamiento farmacológico , Náusea y Vómito Posoperatorios/inducido químicamente , Náusea y Vómito Posoperatorios/epidemiología , Granisetrón , Método Doble CiegoRESUMEN
INTRODUCTION: Post-operative nausea and vomiting (PONV) is a common problem after sleeve gastrectomy. In recent years, following the increase in the number of such operations, special attention has been paid to preventing PONV. Additionally, several prophylaxis methods have been developed, including enhanced recovery after surgery (ERAS) and preventive antiemetics. Nevertheless, PONV has not been completely eliminated, and the clinicians are trying to reduce the incidence of PONV yet. METHODS: After successful ERAS implementation, patients were divided into five groups, including control and experimental groups. Metoclopramide (MA), ondansetron (OA), granisetron (GA), and a combination of metoclopramide and ondansetron (MO) were used as antiemetics for each group. The frequency of PONV during the first and second days of admission was recorded using a subjective PONV scale. RESULTS: A total of 130 patients were enrolled in this study. The MO group showed a lower incidence of PONV (46.1%) compared to the control group (53.8%) and other groups. Furthermore, the MO group did not require rescue antiemetics, however, one-third of control cases used rescue antiemetics (0 vs. 34%). CONCLUSION: Using the combination of metoclopramide and ondansetron is recommended as the antiemetic regimen for the reduction of PONV after sleeve gastrectomy. This combination is more helpful when implemented alongside ERAS protocols.