RESUMEN
Importance: In cardiac surgery, albumin solution may maintain hemodynamics better than crystalloids and reduce the decrease in platelet count and excessive fluid balance, but randomized trials are needed to compare the effectiveness of these approaches in reducing surgical complications. Objective: To assess whether 4% albumin solution compared with Ringer acetate as cardiopulmonary bypass prime and perioperative intravenous volume replacement solution reduces the incidence of major perioperative and postoperative complications in patients undergoing cardiac surgery. Design, Setting, and Participants: A randomized, double-blind, single-center clinical trial in a tertiary university hospital during 2017-2020 with 90-day follow-up postoperatively involving patients undergoing on-pump coronary artery bypass grafting; aortic, mitral, or tricuspid valve surgery; ascending aorta surgery without hypothermic circulatory arrest; and/or the maze procedure were randomly assigned to 2 study groups (last follow-up was April 13, 2020). Interventions: The patients received in a 1:1 ratio either 4% albumin solution (n = 693) or Ringer acetate solution (n = 693) as cardiopulmonary bypass priming and intravenous volume replacement intraoperatively and up to 24 hours postoperatively. Main Outcomes and Measures: The primary outcome was the number of patients with at least 1 major adverse event: death, myocardial injury, acute heart failure, resternotomy, stroke, arrhythmia, bleeding, infection, or acute kidney injury. Results: Among 1407 patients randomized, 1386 (99%; mean age, 65.4 [SD, 9.9] years; 1091 men [79%]; 295 women [21%]) completed the trial. Patients received a median of 2150 mL (IQR, 1598-2700 mL) of study fluid in the albumin group and 3298 mL (IQR, 2669-3500 mL) in the Ringer group. The number of patients with at least 1 major adverse event was 257 of 693 patients (37.1%) in the albumin group and 234 of 693 patients (33.8%) in the Ringer group (relative risk albumin/Ringer, 1.10; 95% CI, 0.95-1.27; P = .20), an absolute difference of 3.3 percentage points (95% CI, -1.7 to 8.4). The most common serious adverse events were pulmonary embolus (11 [1.6%] in the albumin group vs 8 [1.2%] in the Ringer group), postpericardiotomy syndrome (9 [1.3%] in both groups), and pleural effusion with intensive care unit or hospital readmission (7 [1.0%] in the albumin group vs 9 [1.3%] in the Ringer group). Conclusions and Relevance: Among patients undergoing cardiac surgery with cardiopulmonary bypass, treatment with 4% albumin solution for priming and perioperative intravenous volume replacement solution compared with Ringer acetate did not significantly reduce the risk of major adverse events over the following 90 days. These findings do not support the use of 4% albumin solution in this setting. Trial Registration: ClinicalTrials.gov Identifier: NCT02560519.
Asunto(s)
Albúminas , Procedimientos Quirúrgicos Cardíacos , Puente Cardiopulmonar , Fluidoterapia , Cardiopatías , Soluciones Isotónicas , Anciano , Albúminas/administración & dosificación , Albúminas/efectos adversos , Albúminas/uso terapéutico , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/métodos , Puente Cardiopulmonar/efectos adversos , Puente Cardiopulmonar/métodos , Puente de Arteria Coronaria/efectos adversos , Puente de Arteria Coronaria/métodos , Método Doble Ciego , Femenino , Fluidoterapia/efectos adversos , Fluidoterapia/métodos , Cardiopatías/cirugía , Cardiopatías/terapia , Humanos , Soluciones Isotónicas/administración & dosificación , Soluciones Isotónicas/efectos adversos , Soluciones Isotónicas/uso terapéutico , Masculino , Persona de Mediana Edad , Soluciones/administración & dosificación , Soluciones/efectos adversos , Soluciones/uso terapéuticoRESUMEN
PURPOSE: The objective of this work was to systematically evaluate the effects of formulation composition on subcutaneous injection site pain (ISP) using matrices comprising of common pharmaceutical excipients. METHODS: Two randomized, blinded, crossover studies in healthy subjects were conducted at a single site, where subjects received 1 mL SC injections of the buffer matrices. ISP intensity was measured using a 100 mm visual analogue scale (VAS), which was then analyzed via heatmap, categorical grouping, subgroup analysis, and paired delta analysis. RESULTS: Buffer type, buffer concentration and tonicity agent showed a substantial impact on ISP. Citrate buffer demonstrated a higher ISP than acetate buffer or saline). The 20 mM citrate buffer was more painful than 10 or 5 mM citrate buffers. NaCl and propylene glycol were significantly more painful than sugar alcohols (mannitol, sucrose, trehalose or glycerol). Histidine buffers exhibited ISP in the descending order of 150 mM > 75 mM > 25 mM > 0 mM NaCl, while histidine buffers containing Arginine-HCl at 0, 50, or 150 mM all showed very low ISP. Histidine buffer at pH 6.5 showed a lower ISP than pH 5.7. CONCLUSIONS: This systematic study via orthogonal analyses demonstrated that subcutaneous ISP is significantly influenced by solution composition.
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Excipientes/efectos adversos , Reacción en el Punto de Inyección/etiología , Dolor/etiología , Soluciones/efectos adversos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Tampones (Química) , Estudios Cruzados , Excipientes/química , Femenino , Voluntarios Sanos , Humanos , Concentración de Iones de Hidrógeno , Reacción en el Punto de Inyección/diagnóstico , Reacción en el Punto de Inyección/prevención & control , Inyecciones Subcutáneas/efectos adversos , Masculino , Persona de Mediana Edad , Dolor/diagnóstico , Dolor/prevención & control , Dimensión del Dolor , Soluciones/administración & dosificación , Soluciones/química , Adulto JovenRESUMEN
BACKGROUND: Histidine-tryptophan-ketoglutarate (HTK) and del Nido (DN) cardioplegia are intracellular-type and extracellular-type solution respectively, both can provide a long period of myocardial protection with single-dose infusion, but studies comparing the two are rare for adult cardiac surgery. This study aims to evaluate whether DN is suitable for cardioplegia in complex and high-risk valve surgery with long-term cardiac ischemia when compared with HTK. METHODS: The perioperative records of adult patients infused with DN/HTK as a cardioplegic solution who underwent complex valve surgery with an expected myocardial ischaemic duration longer than 90 min between Oct 2018 and Oct 2019 were analysed retrospectively. RESULTS: Of the 160 patients who received DN/HTK and underwent complex valve surgery, we propensity matched 73 pairs. Both groups achieved satisfactory cardiac arrest effects, and no significant difference was found in their cTnI and CK-MB levels within 12 to 72 h postoperatively. The DN group had a higher rate of return to spontaneous rhythm (0.88 v 0.52, P < 0.001), a lower frequency of postoperative severe arrythmias (12% v 26%, P = 0.036), a higher postoperative stroke volume (65 v 59 ml, P = 0.011) and a higher cardiac output (6.0 v 4.9 L/min, P = 0.007) as evaluated by echocardiography, fewer transfusions and shorter ICU stays (both P < 0.05). The two groups had similar inotrope usage and similar incidences of low cardiac output, morbidities and mortality. Subgroup analysis showed that when the aortic clamping time was greater than 120 min, the advantages of DN were weakened. CONCLUSIONS: DN can be safely applied to complex valve surgery, and it has a similar myocardial protection effect as HTK. Further prospective studies are required to verify these retrospective findings. Trial registration retrospectively registered.
Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Electrólitos/administración & dosificación , Paro Cardíaco Inducido , Enfermedades de las Válvulas Cardíacas/cirugía , Válvulas Cardíacas/cirugía , Lidocaína/administración & dosificación , Sulfato de Magnesio/administración & dosificación , Manitol/administración & dosificación , Cloruro de Potasio/administración & dosificación , Bicarbonato de Sodio/administración & dosificación , Soluciones/administración & dosificación , Adolescente , Adulto , Anciano , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Electrólitos/efectos adversos , Femenino , Glucosa/administración & dosificación , Glucosa/efectos adversos , Paro Cardíaco Inducido/efectos adversos , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Enfermedades de las Válvulas Cardíacas/fisiopatología , Válvulas Cardíacas/diagnóstico por imagen , Válvulas Cardíacas/fisiopatología , Humanos , Lidocaína/efectos adversos , Sulfato de Magnesio/efectos adversos , Masculino , Manitol/efectos adversos , Persona de Mediana Edad , Tempo Operativo , Complicaciones Posoperatorias/etiología , Cloruro de Potasio/efectos adversos , Procaína/administración & dosificación , Procaína/efectos adversos , Recuperación de la Función , Estudios Retrospectivos , Bicarbonato de Sodio/efectos adversos , Soluciones/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Del Nido cardioplegia (DNC) has been proven safe and effective in pediatric patients. However, the use of DNC in adult undergoing cardiovascular surgery lacks support with substantial evidence. This study aimed to evaluate the efficacy of DNC as a cardioplegia of prophylaxis to ventricular arrhythmias associated to cardiovascular surgery in adult patients. METHODS: This study recruited nine hundred fifty-four patients who underwent cardiopulmonary bypass surgeries in Nanjing Hospital affiliated to Nanjing Medical University between January 2019 and December 2019. Among 954 patients, 324 patients were treated with DNC (DNC group), and 630 patients were treated with St. Thomas cardioplegia (STH group). The incidence of postoperative arrhythmia as well as other cardiovascular events relavant to the surgery were investigated in both groups. RESULTS: In DNC group, the incidence of postoperative ventricular arrhythmias was lower (12.4% vs. 17.4%, P = 0.040), and the length of ICU stay was shorter (1.97 ± 1.49 vs. 2.26 ± 1.46, P = 0.004). Multivariate logistic regression demonstrated that the use of DNC helped to reduce the incidence of postoperative ventricular arrhythmias (adjusted odds ratio 0.475, 95% CI 0.266-0.825, P = 0.010). The propensity score-based analysis and subgroup analysis indicated that DNC has the same protecting effects towards myocardial in all kinds of cardiopulmonary bypass surgeries. CONCLUSIONS: Del Nido cardioplegia may potentially reduce the incidence of postoperative ventricular arrhythmias, shorten the length of ICU stay and improve the overall outcome of the patients undergoing cardiovascular surgery.
Asunto(s)
Arritmias Cardíacas/prevención & control , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Soluciones Cardiopléjicas/uso terapéutico , Puente Cardiopulmonar/efectos adversos , Electrólitos/uso terapéutico , Paro Cardíaco Inducido , Lidocaína/uso terapéutico , Sulfato de Magnesio/uso terapéutico , Manitol/uso terapéutico , Cloruro de Potasio/uso terapéutico , Bicarbonato de Sodio/uso terapéutico , Soluciones/uso terapéutico , Adulto , Anciano , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/epidemiología , Bicarbonatos/efectos adversos , Bicarbonatos/uso terapéutico , Cloruro de Calcio/efectos adversos , Cloruro de Calcio/uso terapéutico , Soluciones Cardiopléjicas/efectos adversos , China/epidemiología , Electrólitos/efectos adversos , Femenino , Paro Cardíaco Inducido/efectos adversos , Humanos , Incidencia , Unidades de Cuidados Intensivos , Tiempo de Internación , Lidocaína/efectos adversos , Magnesio/efectos adversos , Magnesio/uso terapéutico , Sulfato de Magnesio/efectos adversos , Masculino , Manitol/efectos adversos , Persona de Mediana Edad , Cloruro de Potasio/efectos adversos , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Bicarbonato de Sodio/efectos adversos , Cloruro de Sodio/efectos adversos , Cloruro de Sodio/uso terapéutico , Soluciones/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Exclusive use of Del Nido cardioplegia administration in all adult patients undergoing cardiac surgery has been studied for operative, postoperative and myocardial protection outcomes. METHODS: From November 2016 to October 2017, Del Nido cardioplegia was used in 131 consecutive patients (DN group). Using a propensity score, DN group was compared to 251 patients having received intermittent cold blood cardioplegia (CB group). RESULTS: Preoperative characteristics were similar in DN and CB groups. Operative outcomes were statistically different (p < 0.0001): cardiopulmonary bypass (CPB) time (DN 105.9 ± 46.5, CB 131.2 ± 38.8); aortic cross-clamp time (DN 80.8 ± 35.5, CB 102.2 ± 31.3); operative time (DN 203.1 ± 65.0, CB 241.5 ± 54.7); total cardioplegia volume (DN 1328 ± 879, CB 3773 ± 1226); and peak glycemia on CPB (DN 8.2 ± 2.3, CB 9.0 ± 1.8). No statistical differences were noted in intensive care unit stay, hospital stay and hospital death. Myocardial protection outcomes were similar: discharge left ventricular ejection fraction (DN 52 ± 11, CB 51 ± 10); Troponin levels at the end of the surgery (DN 871 ± 1623, CB 1958 ± 854), day 1 (DN 853 ± 1139, CB 993 ± 8234) and day 4 (DN 442 ± 540, CB 463 ± 317). CONCLUSION: Del Nido cardioplegia use in all adult cardiac surgeries is associated with improved surgical efficiency. The design of larger trials including adults combined cardiac procedures and emergencies is needed.
Asunto(s)
Soluciones Cardiopléjicas/administración & dosificación , Electrólitos/administración & dosificación , Paro Cardíaco Inducido , Lidocaína/administración & dosificación , Sulfato de Magnesio/administración & dosificación , Manitol/administración & dosificación , Cloruro de Potasio/administración & dosificación , Bicarbonato de Sodio/administración & dosificación , Soluciones/administración & dosificación , Anciano , Soluciones Cardiopléjicas/efectos adversos , Electrólitos/efectos adversos , Femenino , Paro Cardíaco Inducido/efectos adversos , Paro Cardíaco Inducido/mortalidad , Humanos , Tiempo de Internación , Lidocaína/efectos adversos , Sulfato de Magnesio/efectos adversos , Masculino , Manitol/efectos adversos , Persona de Mediana Edad , Tempo Operativo , Complicaciones Posoperatorias/etiología , Cloruro de Potasio/efectos adversos , Estudios Retrospectivos , Bicarbonato de Sodio/efectos adversos , Soluciones/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
Molluscum contagiosum is a common childhood condition, and although it is self-limited, treatments are often prescribed. Several medications are available, but there is no consensus regarding the optimal choice in the pediatric population. We report a child who underwent potassium hydroxide 5% treatment resulting in superficial diffuse erosions caused by the inappropriate application. This underlines the importance of parent education before use of this medication with well-known caustic properties.
Asunto(s)
Antivirales/efectos adversos , Fármacos Dermatológicos/efectos adversos , Hidróxidos/efectos adversos , Molusco Contagioso/tratamiento farmacológico , Compuestos de Potasio/efectos adversos , Úlcera Cutánea/inducido químicamente , Administración Tópica , Antivirales/administración & dosificación , Dorso , Preescolar , Fármacos Dermatológicos/administración & dosificación , Humanos , Hidróxidos/administración & dosificación , Masculino , Cumplimiento de la Medicación , Cuello , Necrosis , Compuestos de Potasio/administración & dosificación , Hombro , Piel/efectos de los fármacos , Piel/patología , Soluciones/administración & dosificación , Soluciones/efectos adversos , Resultado del TratamientoRESUMEN
Glucagon secreted from the pancreatic alpha-cells is essential for regulation of blood glucose levels. However, glucagon may play an equally important role in the regulation of amino acid metabolism by promoting ureagenesis. We hypothesized that disruption of glucagon receptor signaling would lead to an increased plasma concentration of amino acids, which in a feedback manner stimulates the secretion of glucagon, eventually associated with compensatory proliferation of the pancreatic alpha-cells. To address this, we performed plasma profiling of glucagon receptor knockout ( Gcgr-/-) mice and wild-type (WT) littermates using liquid chromatography-mass spectrometry (LC-MS)-based metabolomics, and tissue biopsies from the pancreas were analyzed for islet hormones and by histology. A principal component analysis of the plasma metabolome from Gcgr-/- and WT littermates indicated amino acids as the primary metabolic component distinguishing the two groups of mice. Apart from their hyperaminoacidemia, Gcgr-/- mice display hyperglucagonemia, increased pancreatic content of glucagon and somatostatin (but not insulin), and alpha-cell hyperplasia and hypertrophy compared with WT littermates. Incubating cultured α-TC1.9 cells with a mixture of amino acids (Vamin 1%) for 30 min and for up to 48 h led to increased glucagon concentrations (~6-fold) in the media and cell proliferation (~2-fold), respectively. In anesthetized mice, a glucagon receptor-specific antagonist (Novo Nordisk 25-2648, 100 mg/kg) reduced amino acid clearance. Our data support the notion that glucagon secretion and hepatic amino acid metabolism are linked in a close feedback loop, which operates independently of normal variations in glucose metabolism.
Asunto(s)
Aminoácidos/efectos adversos , Aminoácidos/sangre , Comunicación Celular , Células Secretoras de Glucagón/fisiología , Hepatocitos/fisiología , Receptores de Glucagón/genética , Animales , Comunicación Celular/efectos de los fármacos , Comunicación Celular/genética , Proliferación Celular/efectos de los fármacos , Proliferación Celular/genética , Electrólitos/efectos adversos , Electrólitos/sangre , Femenino , Células Secretoras de Glucagón/efectos de los fármacos , Células Secretoras de Glucagón/patología , Glucosa/efectos adversos , Hepatocitos/efectos de los fármacos , Hiperplasia/genética , Hiperplasia/metabolismo , Hiperplasia/patología , Hígado/efectos de los fármacos , Hígado/fisiología , Masculino , Ratones , Ratones Endogámicos C57BL , Ratones Noqueados , Transducción de Señal/genética , Soluciones/efectos adversosRESUMEN
BACKGROUND: Intradermal test is used to detect causative allergens in IgE-mediated hypersensitivity. The surfactant polysorbate 80 can be added to intradermal test solutions to more reliably dissolve the allergen and ensure a constant bioavailability of the injected allergen. Polysorbate 80 has, however, some histamine-releasing properties which could blur the difference to the histamine-induced wheal. Routinely serving as a control. OBJECTIVE: Allergen-free polysorbate 80 containing (0.005%) test solutions were therefore systematically tested at different injection volumes to see whether polysorbate can falsify skin reactions and if yes whether conditions can be identified to avoid this. METHODS: In a partly blinded study, 30 patients were tested intracutaneously at the back: each received at three separate sites 0.05 mL of polysorbate-containing solvent, 0.02 mL polysorbate-containing solvent as well as 0.02 mL polysorbate-free solvent. After 15 min, wheal and erythema were documented and planimetrically quantified. RESULTS: Unexpectedly 23 of 30 (77%) patients showed false-positive test reactions to the volume of 0.05 mL of the polysorbate-containing solvent whereas the polysorbate-containing solvent with 0.02 mL and the polysorbate-free solvent with 0.02 mL injection volume had no reinforcing effect on skin test reaction. CONCLUSIONS: Different volumes of polysorbate-containing solutions, all recommended by manufacturers for intradermal tests, may significantly influence test results. The study shows that a polysorbate 80 used at 0.005% in solvents for intradermal test to provide a better bioavailability of allergens produces false-positive reactivity in a surprising and a hitherto unknown 77% if the 0.05 mL volume is injected. It is, therefore, mandatory to strictly adhere to an intradermal test volume of 0.02 mL as only then falsifying effects of the polysorbate additive are avoided, and comparable test results are ensured.
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Alérgenos/inmunología , Hipersensibilidad/diagnóstico , Polisorbatos/efectos adversos , Polisorbatos/farmacología , Pruebas Cutáneas/métodos , Adulto , Estudios de Cohortes , Intervalos de Confianza , Relación Dosis-Respuesta a Droga , Reacciones Falso Positivas , Femenino , Humanos , Pruebas Intradérmicas/métodos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Medición de Riesgo , Sensibilidad y Especificidad , Soluciones/efectos adversos , Adulto JovenRESUMEN
AIM: The aim of this study was to assess the cariogenic potential of the commonly prescribed pediatric liquid medicaments (PLMs) for dental disease in Jazan region, Kingdom of Saudi Arabia. MATERIALS AND METHODS: Seven most commonly prescribed PLMs were selected by prior questioning the pediatric dentists as well as general dentists in Jazan region. The endogenous pH and sucrose concentrations of the liquid medicaments were assessed. The endogenous pH was assessed by Hanna pH meter instrument. The sucrose concentration was assessed by anthrone reagent method. RESULTS: All the PLM were acidic. The pH of the PLM ranged from 4.22 to 6.10. All the PLM contained sucrose and its concentration ranged from 5.38 to 11.41 gm% in the samples. CONCLUSION: In this study, all the PLM were acidic and contained sucrose. Hence, they have cariogenic potential. CLINICAL SIGNIFICANCE: Parents and dentists are unaware of the hidden sugars and cariogenicity of these medications. Strict oral hygiene instructions are mandatory for the children taking these medications. The use of PLM should also be minimized and parents should seek early dental treatment to restore child's oral health.
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Cariogénicos/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Preparaciones Farmacéuticas/administración & dosificación , Soluciones/efectos adversos , Cariogénicos/administración & dosificación , Niño , Humanos , Concentración de Iones de Hidrógeno , Técnicas In Vitro , Arabia Saudita , Soluciones/química , Sacarosa/efectos adversos , Sacarosa/análisisRESUMEN
AIMS: The aim of the present study was to investigate the safety, tolerability, dose proportionality and relative bioavailability of tablet and oral solution formulations of BI 409306 in healthy male subjects, and to compare the safety and pharmacokinetics in subjects who were extensive metabolizers (EMs) or poor metabolizers (PMs) of cytochrome P450 (CYP)-2C19. METHODS: The present randomized, double-blind, placebo-controlled, single-centre study evaluated single rising doses of BI 409306 (0.5-500 mg) administered as a tablet or oral solution to EMs or PMs. RESULTS: Of 80 enrolled subjects (mean age 36.7 years), 79 (CYP2C19 EMs, 71; CYP2C19 PMs, eight) received treatment and completed the study. Adverse events (AEs) were mild to moderate in intensity. Overall, 17/71 (23.9%) EMs and 6/8 (75.0%) PMs experienced 28 and eight AEs, respectively, of which, 25 and seven AEs, respectively, were considered to be drug related. The most frequently reported AEs were nervous system and eye disorders; all occurred shortly (20-30 min) after administration and mostly resolved within 1-2 h. No serious AEs occurred. BI 409306 systemic absorption and elimination were rapid; peak plasma concentration (Cmax ) was reached <1 h after drug administration, and the half-life ranged from 0.99 h to 2.71 h. Both the tablet and oral solution resulted in similar exposures. In PMs, at dose levels of 10 mg and 100 mg, Cmax was 2.2-2.3-fold higher, and the area under the plasma concentration-time curve over the time interval 0 extrapolated to infinity was 4.1-5.0-fold higher compared with EMs. CONCLUSIONS: In healthy male subjects, BI 409306 was generally safe and well tolerated, with rapid absorption and elimination. Systemic exposure was higher in CYP2C19 PMs than EMs at the same dose level.
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3',5'-AMP Cíclico Fosfodiesterasas/antagonistas & inhibidores , Administración Oral , Adulto , Disponibilidad Biológica , Citocromo P-450 CYP2C19/genética , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de Fosfodiesterasa/administración & dosificación , Inhibidores de Fosfodiesterasa/efectos adversos , Inhibidores de Fosfodiesterasa/farmacocinética , Soluciones/administración & dosificación , Soluciones/efectos adversos , Soluciones/farmacocinética , Comprimidos/administración & dosificación , Comprimidos/efectos adversos , Comprimidos/farmacocinética , Adulto JovenRESUMEN
OBJECTIVES: To estimate the efficacy and side effects of Monsel solution for hemostasis after cervical punch biopsy. METHODS: In a prospective, randomized trial, we compared application of Monsel solution versus a "wait and see" approach in women undergoing cervical punch biopsies in a 1:1 ratio. The primary end point was vaginal bleeding (VB) after 15 minutes measured by scoring a sanitary pad with a 5-level pictogram. Secondary end points were VB after 3, 6, and 24 hours (5-level pictogram), subjective estimation of overall VB during 24 hours, pain after 15 minutes and subjective estimation of overall pain after 24 hours, and overall satisfaction after 24 hours (11-level visual analogue scale). RESULTS: One hundred forty-five women were randomized between July 2015 and January 2016. Mean objective VB scores after 15 minutes in 75 women with Monsel solution were 1.2 ± 0.6 compared with 1.8 ± 1.0 in 70 women without Monsel solution (P < 0.001). The secondary end points VB after 3 and 6 hours, but not after 24 hours, were also in favor of Monsel solution (2.1 ± 1.1 vs 2.9 ± 1.2; P < 0.001; 1.6 ± 0.7 vs 2.2 ± 1.0; P < 0.001; 1.6 ± 0.9 vs 1.7 ± 0.9; P = 0.4, respectively). Subjective estimation of overall VB during 24 hours was lower for Monsel solution (23.2 ± 15.8 vs 35.9 ± 19.5; P < 0.001), but pain after 15 minutes, overall pain, and overall satisfaction were not significantly different between groups (19.2 ± 14.4 vs 17.9 ± 16.2; P = 0.3; 20.7 ± 15.8 vs 20.1 ± 18.0; P = 0.5; and 44.1 ± 21.5 vs 43.6 ± 23.2; P = 0.9, respectively). CONCLUSIONS: Application of Monsel solution significantly reduces bleeding for 6 hours after cervical biopsy but does not affect overall pain or overall satisfaction.
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Biopsia , Hemorragia/tratamiento farmacológico , Hemostasis Quirúrgica/métodos , Hemostáticos/administración & dosificación , Soluciones/administración & dosificación , Adulto , Femenino , Hemostáticos/efectos adversos , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Soluciones/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
On December 23, 2014, the New York State Department of Health (NYSDOH) was notified of adverse health events in two patients who had been inadvertently administered nonsterile, simulation 0.9% sodium chloride intravenous (IV) fluids at an urgent care facility. Simulation saline is a nonsterile product not meant for human or animal use; it is intended for use by medical trainees practicing IV administration of saline on mannequins or other training devices. Both patients experienced a febrile illness during product administration and were hospitalized; one patient developed sepsis and disseminated intravascular coagulation. Neither patient died. Staff members at the clinic reported having ordered the product through their normal medical supply distributor and not recognizing during administration that it was not intended for human use.
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Coagulación Intravascular Diseminada/etiología , Contaminación de Medicamentos , Sepsis/etiología , Cloruro de Sodio/administración & dosificación , Cloruro de Sodio/efectos adversos , Soluciones/administración & dosificación , Soluciones/efectos adversos , Humanos , Inyecciones Intravenosas/efectos adversos , Maniquíes , New York , Simulación de Paciente , Estados UnidosRESUMEN
BACKGROUND: One small study suggests that gargling with licorice before induction of anesthesia reduces the risk of postoperative sore throat. Double-lumen tubes are large and thus especially likely to provoke sore throats. We therefore tested the hypothesis that preoperative gargling with licorice solution prevents postoperative sore throat and postextubation coughing in patients intubated with double-lumen tubes. METHODS: We enrolled 236 patients having elective thoracic surgery who required intubation with a double-lumen endotracheal tube. Patients were randomly assigned to gargle 5 minutes before induction of anesthesia for 1 minute with: (1) Extractum Liquiritiae Fluidum (licorice 0.5 g); or (2) Sirupus Simplex (sugar 5 g); each diluted in 30 mL water. Sore throat and postextubation coughing were evaluated 30 minutes, 90 minutes, and 4 hours after arrival in the postanesthesia care unit, and the first postoperative morning using an 11-point Likert scale by an investigator blinded to treatment. RESULTS: The incidence of postoperative sore throat was significantly reduced in patients who gargled with licorice rather than sugar-water: 19% and 36% at 30 minutes, 10% and 35% at 1.5 hours, and 21% and 45% at 4 hours, respectively. The corresponding estimated treatment effects (relative risks) were 0.54 (95% CI, 0.30-0.99, licorice versus sugar-water; P = 0.005), 0.31 (0.14-0.68) (P < 0.001), and 0.48 (0.28-0.83) (P < 0.001). CONCLUSION: Licorice gargling halved the incidence of sore throat. Preinduction gargling with licorice appears to be a simple way to prevent a common and bothersome complication.
Asunto(s)
Extubación Traqueal/efectos adversos , Carbohidratos/uso terapéutico , Tos/etiología , Tos/prevención & control , Glycyrrhiza , Faringitis/etiología , Faringitis/prevención & control , Complicaciones Posoperatorias/prevención & control , Administración Oral , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Anestesia General , Carbohidratos/efectos adversos , Cuidados Críticos , Método Doble Ciego , Femenino , Glycyrrhiza/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Dolor Postoperatorio/prevención & control , Tamaño de la Muestra , Soluciones/efectos adversos , Soluciones/uso terapéutico , Adulto JovenRESUMEN
BACKGROUND: Platelet transfusions can be associated with adverse reactions, such as febrile non-haemolytic transfusion reaction (FNHTR). It has been suggested that damage-associated molecular patterns (DAMP) and complement play a role in FNHTR. This study investigated the nature of DAMPs and complement activation products contained in platelet concentrates during storage, with a specific focus on different platelet storage solutions. MATERIALS AND METHODS: Buffy coats (BC) from healthy donors were pooled (15 BC per pool) and divided into three groups of the same volume. After addition of different storage solutions (plasma, platelet additive solutions [PAS]-C or PAS-E; n=6 for each group), BC pools were processed to platelet concentrates (PC). Leukoreduced PCs were stored on a shaking bed at 20-24°C and sampled on days 1, 2, 6 and 8 after collection for selected quality parameters: platelet activation, DAMPs (High Mobility Group Box 1 [HMGB1], nucleosomes), and complement activation products. RESULTS: During storage, equal levels of free nucleosomes and increasing concentrations of HMGB1 were present in all groups. Complement activation was observed in all PC. However, by day 8, the use of PAS had reduced C3b/c levels by approximately 90% and C4b/c levels by approximately 65%. DISCUSSION: Nucleosomes and HMGB1 were present in PCs prepared in plasma and PAS. Complement was activated during storage of platelets in plasma and in PAS. The use of PAS is associated with a lower amount of complement activation products due to the dilution of plasma by PAS . Therefore, PC in PAS have less complement activation products than platelets stored in plasma. These proinflammatory mediators in PC might induce FNHTR.
Asunto(s)
Conservación de la Sangre , Activación de Complemento , Plasma , Transfusión de Plaquetas , Soluciones , Reacción a la Transfusión , Humanos , Factores de Coagulación Sanguínea/análisis , Plaquetas , Conservación de la Sangre/efectos adversos , Conservación de la Sangre/métodos , Activación de Complemento/inmunología , Proteína HMGB1/análisis , Nucleosomas/inmunología , Activación Plaquetaria/inmunología , Transfusión de Plaquetas/efectos adversos , Transfusión de Plaquetas/métodos , Soluciones/efectos adversos , Soluciones/farmacología , Soluciones/uso terapéutico , Reacción a la Transfusión/etiología , Reacción a la Transfusión/prevención & control , Plasma/química , Plasma/inmunología , Capa Leucocitaria de la Sangre/química , Capa Leucocitaria de la Sangre/citologíaRESUMEN
The lateral decubitus and beach-chair positions each offer unique benefits to the shoulder surgeon with respect to visualization, efficiency, and ease during arthroscopic shoulder procedures. The purpose of this article was to comprehensively review the reports and studies documenting independent and dependent complications related to patient positioning and anesthesia during arthroscopic shoulder surgery. The lateral decubitus position has been associated with the potential for peripheral neurapraxia, brachial plexopathy, direct nerve injury, and airway compromise. The beach-chair position has been associated with cervical neurapraxia, pneumothorax, and the potential for end-organ hypoperfusion injuries (when deliberate hypotension is used). Potentially concerning are hypotensive bradycardic events, which may be relatively common in association with the use of epinephrine-containing interscalene anesthetics in beach chair-positioned patients. Irrigant complications (fluid spread, ventricular tachycardia) are avoidable risks not unique to either specific position. Although minor transient anesthetic- and position-related complications (neurapraxia, hypotension) may occur in as many 10% to 30% of patients, major complications such as end-organ damage or permanent impairments are exceedingly rare. Regardless of position, complications are almost uniformly avoidable if surgeon and anesthetist exercise care and prudent attention to position and anesthetic choices. The purpose of this article is to review the potential for position- and anesthesia-related complications and acquaint the shoulder surgeon with the proposed pathophysiologic mechanisms that can lead to them.
Asunto(s)
Artroscopía/métodos , Complicaciones Intraoperatorias/etiología , Posicionamiento del Paciente , Complicaciones Posoperatorias/etiología , Postura , Articulación del Hombro/cirugía , Obstrucción de las Vías Aéreas/etiología , Obstrucción de las Vías Aéreas/fisiopatología , Obstrucción de las Vías Aéreas/prevención & control , Anestesia/efectos adversos , Anestesia/métodos , Anestésicos/efectos adversos , Daño Encefálico Crónico/etiología , Daño Encefálico Crónico/fisiopatología , Daño Encefálico Crónico/prevención & control , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/fisiopatología , Enfermedades Cardiovasculares/prevención & control , Potenciales Evocados Somatosensoriales , Humanos , Hipotensión Controlada/efectos adversos , Complicaciones Intraoperatorias/fisiopatología , Complicaciones Intraoperatorias/prevención & control , Isquemia/etiología , Isquemia/fisiopatología , Isquemia/prevención & control , Monitoreo Intraoperatorio , Traumatismos de los Nervios Periféricos , Enfermedades del Sistema Nervioso Periférico/etiología , Enfermedades del Sistema Nervioso Periférico/fisiopatología , Enfermedades del Sistema Nervioso Periférico/prevención & control , Neumotórax/etiología , Neumotórax/fisiopatología , Neumotórax/prevención & control , Complicaciones Posoperatorias/fisiopatología , Complicaciones Posoperatorias/prevención & control , Cuadriplejía/etiología , Cuadriplejía/fisiopatología , Cuadriplejía/prevención & control , Riesgo , Soluciones/efectos adversos , Soluciones/farmacocinética , Médula Espinal/irrigación sanguínea , Irrigación Terapéutica/efectos adversosRESUMEN
BACKGROUND: Studies have shown complications of normal saline infusion because of its high-chloride content. Therefore, in the present study, we aimed to explore whether the use of low- versus high-chloride solutions benefited the unselected and specifically perioperative patients and was associated with different outcomes. METHODS: Studies on the use of low- versus high-chloride content intravenous solutions for perioperative patients, published up to July 15, 2019, were systematically reviewed, and primary and secondary outcomes were quantitatively summarized. RESULTS: A total of 14 eligible randomized controlled trials with 943 perioperative patients were included. Five studies reported all-cause mortality, and eight studies provided detailed data on renal replacement therapy (RRT). The pooled result suggested no statistically significant difference in the effect of low- versus high-chloride solutions on all-cause mortality (risk ratio (RR) = 1.39; 95%confidence interval (CI) = 0.23-8.26) and RRT (RR = 1.05; 95%CI = 0.63-1.76). The pooled results on acute kidney injury (AKI) and the use of allogenic blood transfusion (P > 0.05) were similar. CONCLUSION: Among specific perioperative patients, the use of low- versus high-chloride content intravenous solutions did not reduce the all-cause mortality, risk of severe AKI, or rate of RRT use. Further large randomized clinical trials are needed to confirm or refute this finding.
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Cloruros , Fluidoterapia , Soluciones , Lesión Renal Aguda , Administración Intravenosa , Cloruros/administración & dosificación , Cloruros/efectos adversos , Cloruros/uso terapéutico , Fluidoterapia/efectos adversos , Fluidoterapia/métodos , Fluidoterapia/mortalidad , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Terapia de Reemplazo Renal , Soluciones/administración & dosificación , Soluciones/efectos adversos , Soluciones/uso terapéuticoRESUMEN
OBJECTIVE: Del Nido cardioplegia solution offers prolonged cardiac protection with single-dose administration; this is particularly interesting for aortic root surgery. However, there is a scarcity of data supporting its safety in adults undergoing complex cardiac surgery, such as aortic root repair. We hypothesized that del Nido cardioplegia solution and blood cardioplegia solution provide equivalent safety during aortic root surgery. METHODS: Between January 2015 and June 2018, 283 consecutive patients undergoing the Ross procedure (204) and valve-sparing operation (79) with del Nido cardioplegia solution or blood cardioplegia solution were 1:1 propensity matched (110 aortic root surgery), and outcomes were compared. Clinical patient characteristics and data were extracted from our local database for valve-sparing operations and for Ross procedures. RESULTS: Preoperative characteristics were similar between del Nido cardioplegia solution and blood cardioplegia solution after propensity matching (mean age, 48.6 ± 1.5 years). Median postoperative creatine kinase MB isotype did not differ between del Nido cardioplegia solution and blood cardioplegia solution (48.9 [14.9-300] µg/L vs 51.2 [12.4-116] µg/L for blood cardioplegia solution [P = .1]), but there was a trend toward higher troponin T levels with del Nido cardioplegia solution (748 [221-5834] ng/L vs 710 [212-3332] ng/L for blood cardioplegia solution [P = .07]). In patients with myocardial ischemia longer than 180 minutes, median creatine kinase MB isotype was higher in del Nido cardioplegia solution (75.1 [59.3-300] µg/L than in blood cardioplegia solution 60.5 [16.5-116] µg/L [P = .01]). Aortic crossclamp and cardiopulmonary bypass times were shorter with del Nido cardioplegia solution (163 ± 5 vs 181 ± 5 minutes, P = .01 and 145 ± 4 vs 161 ± 4 minutes, respectively, P = .006). Return to spontaneous rhythm was more frequent in the del Nido cardioplegia solution group (52% [29/55] vs 27% [15/55], P = .006). There was no difference in inotropic or vasoactive agent use (P = .8). Postoperative left ventricle ejection fraction was similar (0.54 ± 0.09 vs 0.55 ± 0.08 for del Nido cardioplegia solution and blood cardioplegia solution, respectively; P = .4). There was no difference between groups for perioperative mortality and postoperative complications. CONCLUSIONS: Del Nido cardioplegia solution can be used as an alternative to blood cardioplegia solution in adults undergoing complex aortic root surgery, providing comparable clinical outcomes and improved surgical workflow. However, del Nido cardioplegia solution seems to be associated with increased myocardial injury, especially with extended myocardial ischemic times, but this finding did not translate into adverse clinical events. Caution is warranted in adopting this cardioplegic solution in aortic interventions requiring long ischemic times, and further study is required to establish its exact role in complex cardiac surgery.
Asunto(s)
Aorta/cirugía , Válvula Aórtica/cirugía , Soluciones Cardiopléjicas/uso terapéutico , Electrólitos/uso terapéutico , Paro Cardíaco Inducido , Lidocaína/uso terapéutico , Sulfato de Magnesio/uso terapéutico , Manitol/uso terapéutico , Cloruro de Potasio/uso terapéutico , Bicarbonato de Sodio/uso terapéutico , Soluciones/uso terapéutico , Procedimientos Quirúrgicos Vasculares , Soluciones Cardiopléjicas/efectos adversos , Electrólitos/efectos adversos , Femenino , Paro Cardíaco Inducido/efectos adversos , Paro Cardíaco Inducido/mortalidad , Mortalidad Hospitalaria , Humanos , Lidocaína/efectos adversos , Sulfato de Magnesio/efectos adversos , Masculino , Manitol/efectos adversos , Persona de Mediana Edad , Tempo Operativo , Complicaciones Posoperatorias/mortalidad , Cloruro de Potasio/efectos adversos , Estudios Retrospectivos , Bicarbonato de Sodio/efectos adversos , Soluciones/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Procedimientos Quirúrgicos Vasculares/efectos adversos , Procedimientos Quirúrgicos Vasculares/mortalidadRESUMEN
BACKGROUND: Despite the increasing popularity of single-dose cardioplegia techniques in coronary artery bypass grafting, the time window for successful reperfusion remains unclear. This study aimed to compare different cardioplegic techniques based on early and 30-day clinical outcomes via thorough monitoring. METHODS: This prospective cohort study included high-risk patients undergoing coronary artery bypass grafting and receiving 3 different types of cardioplegia between January 2017 and June 2019. Group 1 (n = 101) had a single dose of del Nido cardioplegia, group 2 (n = 92) had a single dose of histidine-tryptophane-ketoglutarate, and group 3 (n = 119) had cold blood cardioplegia. Patients were examined perioperatively by memory loop recording and auto-triggered memory loop recording for 30 days, with documentation of predefined events. RESULTS: Interleukin-6 and cardiac troponin levels in group 1 were significantly higher than those in groups 2 and 3. The incidence of predefined events as markers of inadequate myocardial protection was significantly higher group 1, with more frequent atrial fibrillation attacks and more hospital readmissions. The readmission rate was 17.6% in group 1, 9% in group 2, and 8% in group 3. CONCLUSIONS: Our data demonstrate the long-term efficacy of cardioplegic techniques, which may become more crucial in high-risk patients who genuinely have a chance to benefit from adjunct myocardial protection. Patients given del Nido cardioplegia had a significantly more prominent inflammatory response and higher troponin levels after cardiopulmonary bypass. This group had issues in the longer term with significantly more cardiac events and a higher rehospitalization rate.
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Frío , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/cirugía , Electrólitos/uso terapéutico , Paro Cardíaco Inducido , Lidocaína/uso terapéutico , Sulfato de Magnesio/uso terapéutico , Manitol/uso terapéutico , Cloruro de Potasio/uso terapéutico , Bicarbonato de Sodio/uso terapéutico , Soluciones/uso terapéutico , Anciano , Biomarcadores/sangre , Frío/efectos adversos , Puente de Arteria Coronaria/efectos adversos , Electrólitos/efectos adversos , Femenino , Glucosa/efectos adversos , Glucosa/uso terapéutico , Paro Cardíaco Inducido/efectos adversos , Humanos , Interleucina-6/sangre , Lidocaína/efectos adversos , Sulfato de Magnesio/efectos adversos , Masculino , Manitol/efectos adversos , Persona de Mediana Edad , Readmisión del Paciente , Complicaciones Posoperatorias/sangre , Complicaciones Posoperatorias/terapia , Cloruro de Potasio/efectos adversos , Procaína/efectos adversos , Procaína/uso terapéutico , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Bicarbonato de Sodio/efectos adversos , Soluciones/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Troponina/sangreRESUMEN
BACKGROUND: The evidence regarding the impact of patient's age and gender on del Nido cardioplegia cadio-protection capability in adults is strongly limited. METHODS: A group of 75 patients undergoing aortic valve replacement (AVR) with del Nido cardioplegia was divided into Group 1 (male) and Group 2 (female). Creatine kinase (CK-MB isoenzyme) and high sensitivity troponin T (hs-TnT) values at 24 hours and 48 hours, occurrence of cardiac activity during crossclamp and ventricular fibrillation (VF) during reperfusion were compared. The impact of age on hs-TnT,CK-MB, VF during reperfusion and cardiac activity during crossclamp was investigated using regression models. RESULTS: No difference between the groups was reported in 24-hour CK-MB (median 15.57 ng/mL; IQR 12.13-22.82 ng/mL vs. 13.97; 12.09-17.147 ng/mL; P=0.168), 48-hour CK-MB (6.19; 4.22-7.71 ng/mL vs. 6.07;4.56-7.06 ng/mL; P=0.707), 24-hour hs-TnT (259.2; 172.0-376.9 pg/mL vs. 193.0; 167.8-351 pg/mL.1; P=0.339), 48-hour hs-TnT (169.1; 124.9-293.0 pg/mL vs. 159.2; 123.12-211.77 pg/mL; P=0.673), VF during reperfusion (25% vs. 18,5%; P=0.774) and cardiac activity during arrest (39.6% vs. 37.1%; p= 1.0). Values of CK-MB at 24 hours, hs-TnT at 24 hours and hs-TnT at 48 hours were not dependent on age. The CK-MB at 48 hours was dependent on age (P=0.039). Probit regression failed to reveal the impact of patients' age on postclamp VF occurrence (P=0.11) or electrical activity during arrest (P=0.57). CONCLUSIONS: Considering our study results, it can be hypothesized that the del Nido cardioplegia provides adequate myocardial protection in AVR patients regardless of age and gender.