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Background and Objectives: The relationship between histidine-tryptophan-ketoglutarate (HTK)-induced hyponatremia and brain injury in adult cardiac surgery patients is unclear. This study analyzed postoperative neurological outcomes after intraoperative HTK cardioplegia infusion. Materials and Methods: A prospective cohort study was conducted on 60 adult patients who underwent cardiac surgery with cardiopulmonary bypass. Of these patients, 13 and 47 received HTK infusion and conventional hyperkalemic cardioplegia, respectively. The patients' baseline characteristics, intraoperative data, brain injury markers, Mini-Mental State Examination (MMSE) scores, and quantitative electroencephalography (qEEG) data were collected. Electrolyte changes during cardiopulmonary bypass, the degree of hyponatremia, and any associated brain insults were evaluated. Results: The HTK group presented with acute hyponatremia during cardiopulmonary bypass, which was intraoperatively corrected through ultrafiltration and normal saline administration. Postoperative sodium levels were higher in the HTK group than in the conventional cardioplegia group. The change in neuron-specific enolase levels after cardiopulmonary bypass was significantly higher in the HTK group (p = 0.043). The changes showed no significant differences using case-control matching. qEEG analysis revealed a significant increase in relative delta power in the HTK group on postoperative day (POD) 7 (p = 0.018); however, no significant changes were noted on POD 60. The MMSE scores were not significantly different between the two groups on POD 7 and POD 60. Conclusions: HTK-induced acute hyponatremia and rapid correction with normal saline during adult cardiac surgeries were associated with a potential short-term but not long-term neurological impact. Further studies are required to determine the necessity of correction for HTK-induced hyponatremia.
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Procedimientos Quirúrgicos Cardíacos , Paro Cardíaco Inducido , Hiponatremia , Manitol , Procaína , Humanos , Masculino , Hiponatremia/etiología , Femenino , Manitol/administración & dosificación , Manitol/efectos adversos , Manitol/uso terapéutico , Estudios Prospectivos , Persona de Mediana Edad , Procaína/efectos adversos , Procaína/administración & dosificación , Procaína/uso terapéutico , Anciano , Paro Cardíaco Inducido/métodos , Paro Cardíaco Inducido/efectos adversos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/métodos , Soluciones Cardiopléjicas/administración & dosificación , Soluciones Cardiopléjicas/efectos adversos , Soluciones Cardiopléjicas/uso terapéutico , Electroencefalografía/métodos , Glucosa/administración & dosificación , Glucosa/uso terapéutico , Adulto , Estudios de Cohortes , Puente Cardiopulmonar/métodos , Puente Cardiopulmonar/efectos adversos , Cloruro de PotasioRESUMEN
Purpose: This study aimed to determine the onset and duration of action of 3 commercially available topical anesthetic solutions in Brazil, using the Cochet-Bonnet esthesiometer (Luneau®, Paris, France) and to quantitatively assess patient-reported discomfort during application. Methods: A prospective, randomized, masked, and double-blind study was conducted, involving 40 eyes from 21 patients. Patients were administered each one of the topical anesthetics weekly, and corneal sensitivity was measured using the Cochet-Bonnet esthesiometer's corneal touch threshold (CTT). Patients rated the burning sensation using a visual analogue scale (VAS). Results: Among the 21 patients (42.9% male), with a mean age of 31.95 years (±standard deviation = 10.17, range = 22.0-58.0), corneal sensitivity significantly decreased 30 s after application, returning to baseline after 30 min for all groups (P < 0.0001). Significant differences in CTT were observed at 5 min, with proparacaine exhibiting a superior anesthetic effect (P = 0.0003), at 10 min, where tetracaine displayed the most substantial anesthetic effect (P = 0.0135), and at 20 min, where tetracaine demonstrated the highest anesthetic efficacy (P < 0.0001). VAS scores indicated the most intense burning sensation with tetracaine (P < 0.0001). Men reported experiencing more discomfort during instillation compared with women (P = 0.0168). Conclusions: Proparacaine exhibited the fastest onset of action among the 3 topical anesthetics and provided a more comfortable eye sensation during instillation. However, tetracaine demonstrated the longest duration of action despite causing more discomfort.
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Anestésicos Locales , Córnea , Procaína , Propoxicaína , Tetracaína , Humanos , Masculino , Femenino , Tetracaína/administración & dosificación , Tetracaína/farmacología , Adulto , Método Doble Ciego , Propoxicaína/administración & dosificación , Propoxicaína/farmacología , Anestésicos Locales/administración & dosificación , Anestésicos Locales/farmacología , Persona de Mediana Edad , Estudios Prospectivos , Córnea/efectos de los fármacos , Procaína/administración & dosificación , Procaína/farmacología , Procaína/análogos & derivados , Procaína/efectos adversos , Adulto Joven , Soluciones Oftálmicas/administración & dosificación , Dimensión del Dolor/métodosRESUMEN
OBJECTIVE: Spinal anesthesia with local anesthetics is a viable alternative to general anesthesia in orthopedic surgery, and it is currently considered the standard of care for knee arthroscopy. The use of chloroprocaine may offer several potential advantages over other local anesthetics, including, above all, its rapid onset and short duration of action. The aim of the present retrospective study is to evaluate the post-surgical outcomes of patients who underwent knee arthroscopy using spinal anesthesia with chloroprocaine in an outpatient orthopedic setting. PATIENTS AND METHODS: Data from patients who underwent elective knee arthroscopy between January 2022 and December 2022 were collected for the present study. Spinal anesthesia with chloroprocaine 10 mg/mL was administered in the designated subarachnoid space (L3-L4 in the majority of patients). A dosage of 40 mg was used to obtain a satisfactory sensory and motor block. RESULTS: A total number of 302 patients met the inclusion criteria. No complications were reported during surgery in the present series of patients. None of the patients required bladder catheterization. In 84% of cases, the PADSS (Post-Anesthetic Discharge Scoring System) score at discharge was 10, whereas in 16% of cases, the PADSS score was 9. The mean time from anesthesia induction to first urination was 75±9.4 minutes, while the mean time from the anesthesia induction to the discharge from the hospital was 152±18.5 minutes. CONCLUSIONS: Spinal chloroprocaine for knee arthroscopy demonstrated a short motor block duration, resulting in a fast time to discharge. These limited data show that chloroprocaine may be safely and effectively applied in outpatient knee arthroscopy procedures. However, more studies, possibly with a randomized design, are required to confirm these findings.
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Anestesia Raquidea , Anestésicos Locales , Humanos , Artroscopía/efectos adversos , Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Procedimientos Quirúrgicos Ambulatorios/métodos , Estudios Retrospectivos , Procaína/efectos adversos , Anestesia Raquidea/métodos , Método Doble CiegoRESUMEN
Diabetic nephropathy (DN) is a serious devastating disease. However, the current clinical options to treat DN are not adequate. Thus, in the present study, we intend to develop novel series of procaine-embedded thiazole-pyrazoles as protective agent against DN. The compounds were tested for inhibition of dipeptidyl peptidase (DPP)-4, -8, and - 9 enzyme subtypes, where they selectively and potently inhibit DPP-4 as compared to other subtypes. The top three ranked DPP-4 inhibitors (8i, 8e and 8k) were further screened for inhibitory activity against NF-ĸB transcription. Among these three, compound 8i was identified as the most potent NF-ĸB inhibitor. The pharmacological benefit of compound 8i was further established in streptozotocin-induced diabetic nephropathy in rats. Compound 8i showed marked improvements in blood glucose, ALP, ALT, total protein, serum lipid profile such as total cholesterol, triglyceride, HDL levels and renal functions such as urine volume, urinary protein excretion, serum creatinine, blood urea nitrogen and creatinine clearance as compared to nontreated diabetic control group. It also reduces oxidative stress (MDA, SOD and GPx) and inflammation (TNF-α, IL-1ß and IL-6) in the rats as compared to disease control group rats. This study demonstrated the discovery of procaine-embedded thiazole-pyrazole compounds as a novel class of agent against diabetic nephropathy.
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Diabetes Mellitus Experimental , Nefropatías Diabéticas , Ratas , Animales , Nefropatías Diabéticas/tratamiento farmacológico , Anestésicos Locales/efectos adversos , FN-kappa B/metabolismo , Procaína/efectos adversos , Diabetes Mellitus Experimental/tratamiento farmacológico , Diabetes Mellitus Experimental/inducido químicamente , Estrés Oxidativo , Inflamación/tratamiento farmacológico , Inflamación/metabolismo , Riñón/metabolismoRESUMEN
BACKGROUND: Plain 2-chloroprocaine , a rapid acting amino-ester-type local anaesthetic, is used in short ambulatory procedures under spinal anaesthesia. The ED 95 of 2-chloroprocaine for lower limb surgery has not yet been defined. Moreover, patients' body height could influence the effects of the administered dose. OBJECTIVES: The aim of this study was to determine the ED 95 of plain 2-chloroprocaine based on the height of patients undergoing ambulatory knee arthroscopy under spinal anaesthesia using the continual reassessment statistical method (CRM). DESIGN: Prospective, dose-response, double blind, controlled, bi-center, clinical trial. SETTING: One university teaching hospital in Brussels and one general teaching hospital, Braine l'Alleud, Belgium. Université libre de Bruxelles. PATIENTS: ASA I-III (120 patients) scheduled for day-case knee arthroscopy under spinal anaesthesia. INTERVENTIONS: Patients were divided into three groups of 40, each comprising 10 cohorts of 4 patients, according to their respective heights (Group 1: 150-165âcm, Group 2: 166-180âcm, Group 3: 181-195âcm). Each patient enrolled into one of the 3 groups received an intrathecal dose of plain 2-chloroprocaine determined by the CRM. The starting doses for the first cohorts of four were 40âmg in group 1, 45âmg in group 2 and 50âmg in group 3. The doses for subsequent cohorts were determined by CRM of outcomes in all patients in the previous competed cohorts. Anaesthesia was considered successful when there was a lack of pinprick or cold sensation up to T12, the visual analogue scale score for tourniquet pain was < 2 and no pain during surgery. MAIN OUTCOMES: The primary outcome was the success or failure of the block. Side effects were also recorded. RESULTS: ED 95 of 2-chloroprocaine is 40âmg in group 1, 35âmg in group 2, 45âmg in group 3. Groups were different in terms of height and gender ( P â<â0.05) and similar in terms of body mass index and age ( P â>â0.05). CONCLUSION: The ED95 of intrathecal 2-chloroprocaine for patients undergoing ambulatory knee arthroscopy is between 35 and 45âmg. Height could be a factor involved in the calculation, and patient sex could partly explain the nonlinear relation between height and dose. TRIAL REGISTRY NUMBER: Clinicaltrials.gov NCT03882489.
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Anestésicos Locales , Artroplastia de Reemplazo de Rodilla , Estatura , Procaína , Procedimientos Quirúrgicos Ambulatorios , Anestesia Raquidea , Anestésicos Locales/administración & dosificación , Anestésicos Locales/efectos adversos , Artroplastia de Reemplazo de Rodilla/métodos , Método Doble Ciego , Femenino , Humanos , Masculino , Procaína/administración & dosificación , Procaína/efectos adversos , Procaína/análogos & derivados , Estudios ProspectivosRESUMEN
BACKGROUND: Intraperitoneal chloroprocaine has been used during cesarean delivery to supplement suboptimal neuraxial anesthesia for decades. The short in vitro half-life of chloroprocaine (11-21 seconds) has been cited to support the safety of this approach. However, there are no data regarding the rate of absorption, representing patient drug exposure, through this route of administration. Accordingly, we designed a study to determine the in vivo half-life of intraperitoneal chloroprocaine and assess clinical tolerability. METHODS: We designed a single-center, prospective, cohort, multiple-dose escalation study of women 18 to 50 years of age undergoing cesarean delivery with spinal anesthesia. Chloroprocaine (40 mL) was administered after delivery of the newborn and before uterine closure. The first cohort (n = 5) received 1%, the second cohort (n = 5) received 2%, and the third cohort (n = 5) received 3% chloroprocaine solution. Maternal blood samples were obtained before administration and 1, 5, 10, 20, and 30 minutes after dosing. The primary objective was to define the pharmacokinetic profile of intraperitoneal chloroprocaine, including in vivo half-life. The secondary objective was to evaluate tolerability through determination of peak plasma concentration and prospective assessment for local anesthetic systemic toxicity. RESULTS: The peak plasma concentration occurred 5 minutes after intraperitoneal administration in all 3 cohorts: 64.8 ng/mL (6.5 µg/kg), 28.7 ng/mL (2.9 µg/kg), and 799.2 ng/mL (79.9 µg/kg) for 1%, 2%, and 3% chloroprocaine, respectively. The in vivo half-life of chloroprocaine after intraperitoneal administration was estimated to be 5.3 minutes (95% confidence interval, 4.0-6.6). We did not detect clinical signs of local anesthetic systemic toxicity in any of the 3 cohorts. CONCLUSIONS: The in vivo half-life of intraperitoneal chloroprocaine (5.3 minutes) is more than an order of magnitude greater than the in vitro half-life (11-21 seconds). However, maximum plasma concentrations of chloroprocaine (C max range, 0.05-79.9 µg/kg) were not associated with local anesthetic systemic toxicity and remain well below our predefined safe level of exposure (970 µg/kg) and levels associated with clinical symptoms (2.6-2.9 mg/kg). Therefore, our study suggests that intraperitoneal chloroprocaine, in a dosage ≤1200 mg, administered after fetal extraction, is well tolerated during cesarean delivery.
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Anestesia Obstétrica , Anestésicos Locales , Anestésicos Locales/efectos adversos , Femenino , Humanos , Recién Nacido , Embarazo , Procaína/efectos adversos , Procaína/análogos & derivados , Estudios ProspectivosRESUMEN
BACKGROUND: Chloroprocaine is a short-acting local anesthetic that has been used for spinal anesthesia in outpatient surgery. There is limited experience with spinal chloroprocaine for prophylactic cervical cerclage placement. We sought to determine the effective dose of intrathecal chloroprocaine for 90% of patients (ED90) undergoing prophylactic cervical cerclage placement. We hypothesized that the ED90 of intrathecal chloroprocaine when combined with 10-ug fentanyl would be between 33 and 54 mg. METHODS: In this prospective 2-center double-blinded study, we enrolled women undergoing prophylactic cervical cerclage placement under combined spinal-epidural anesthesia. A predetermined dose of intrathecal 3% chloroprocaine with fentanyl 10 ug was administered. The initial dose was 45-mg intrathecal chloroprocaine. Subsequent dose adjustments were determined based on the response of the previous subject using an up-down sequential allocation with a biased-coin design. A dose was considered effective if at least a T12 block was achieved, and there was no requirement for epidural activation or intraoperative analgesic supplementation during the procedure. The primary outcome was the ED90 of intrathecal chloroprocaine with fentanyl 10 ug. Secondary outcomes included duration of surgery, anesthetic side effects, time to resolution of motor and sensory block, time to achieve recovery room discharge criteria, and patient satisfaction with anesthetic care. Isotonic regression was used to estimate the ED90. RESULTS: Forty-seven patients were enrolled into the study. Two patients were excluded (1 protocol violation and 1 failed block). In total, 45 patients completed the study. The estimated ED90 (95% confidence interval) for intrathecal chloroprocaine combined with fentanyl 10 ug was 49.5 mg (45.0-50.1 mg). The median (interquartile range [IQR]) duration of surgery was 15 (10-24) minutes. Resolution of the motor (Bromage 0) and sensory block took a median time of 60 (45-90) minutes and 90 (75-105) minutes, respectively. The median time to achieve recovery room discharge criteria was 150 (139-186) minutes. Satisfaction with anesthetic management was high in all patients. There were no reports of postdural puncture headache or transient neurological symptoms postoperatively. CONCLUSIONS: The ED90 of intrathecal chloroprocaine combined with fentanyl 10 ug was 49.5 mg. Intrathecal chloroprocaine was associated with rapid block recovery and high patient satisfaction, which makes it well suited for outpatient obstetric procedures.
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Anestesia Raquidea , Cerclaje Cervical , Anestesia Raquidea/efectos adversos , Anestesia Raquidea/métodos , Anestésicos Locales/efectos adversos , Bupivacaína , Método Doble Ciego , Femenino , Fentanilo/efectos adversos , Humanos , Embarazo , Procaína/efectos adversos , Procaína/análogos & derivados , Estudios ProspectivosRESUMEN
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.
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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
Since its discovery in 1905 and its employment in everyday medical practice as a local anesthetic, to its highly controversial endorsement as an "anti-aging" molecule in the sixties and seventies, procaine is part of the history of medicine and gerontoprophylaxis. Procaine can be considered a "veteran" drug due to its long-time use in clinical practice, but is also a molecule which continues to incite interest, revealing new biological and pharmacological effects within novel experimental approaches. Therefore, this review is aimed at exploring and systematizing recent data on the biochemical, cellular, and molecular mechanisms involved in the antioxidant and potential geroprotective effects of procaine, focusing on the following aspects: (1) the research state-of-the-art, through an objective examination of scientific literature within the last 30 years, describing the positive, as well as the negative reports; (2) the experimental data supporting the beneficial effects of procaine in preventing or alleviating age-related pathology; and (3) the multifactorial pathways procaine impacts oxidative stress, inflammation, atherogenesis, cerebral age-related pathology, DNA damage, and methylation. According to reviewed data, procaine displayed antioxidant and cytoprotective actions in experimental models of myocardial ischemia/reperfusion injury, lipoprotein oxidation, endothelial-dependent vasorelaxation, inflammation, sepsis, intoxication, ionizing irradiation, cancer, and neurodegeneration. This analysis painted a complex pharmacological profile of procaine: a molecule that has not yet fully expressed its therapeutic potential in the treatment and prevention of aging-associated diseases. The numerous recent reports found demonstrate the rising interest in researching the multiple actions of procaine regulating key processes involved in cellular senescence. Its beneficial effects on cell/tissue functions and metabolism could designate procaine as a valuable candidate for the well-established Geroprotectors database.
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Envejecimiento/efectos de los fármacos , Anestésicos Locales/farmacología , Antioxidantes/farmacología , Procaína/farmacología , Anestésicos Locales/efectos adversos , Animales , Antioxidantes/efectos adversos , Epigénesis Genética/efectos de los fármacos , Humanos , Procaína/efectos adversosRESUMEN
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
OBJECTIVE: Custodiol-HTK cardioplegia (Custodiol-HTK Koheler Chemie, GmbH, Bensheim, Germany) causes fluctuations in serum sodium levels, hyponatremia, and is associated with postoperative seizures. We investigated the influence of scavenging right atrial effluent during delivery on intraoperative serum sodium levels and postoperative seizure incidence in pediatric cardiac surgery patients. METHODS: A total of 204 patients younger than age 18 years undergoing congenital heart surgery between January 2016 and March 2018 were analyzed retrospectively. Serum sodium levels after administration of Custodiol-HTK cardioplegia were compared between the scavenge and nonscavenge groups and then in the propensity score-matched cohort (n = 96). Postoperative seizures were documented clinically and with electroencephalogram findings. Logistic regression models were used to identify the independent predictors of serum sodium level after aortic crossclamp. RESULTS: Of 204 patients, 156 (76.5%) were in the nonscavenge, and 48 (23.5%) in the scavenge groups. A serum sodium level <130 mEq/L after crossclamp and administration of Custodiol-HTK cardioplegia in the nonscavenge group were 70% versus 21% in the scavenge group (odds ratio, 8.8; 95% confidence interval, 4.1-18.3; P < .0001) in the entire cohort, and 77% versus 21% (odds ratio, 12.8; 95% confidence interval, 4.8-33.1; P < .0001) in the propensity score-matched cohort. Of 16 patients experiencing a postoperative seizure, 14 (87.5%) had a sodium level <130 mEq/L and 2 (12.5%) had a sodium level ≥130 mEq/L (odds ratio, 5.1; 95% confidence interval, 1.3-22.8; P = .021) after crossclamp. Postoperative seizures occurred in the nonscavenge group but not the scavenge group in the entire cohort (P = .02) and in the propensity score-matched patients (P = .041). Multivariable analysis of the entire cohort showed that scavenge intervention was an independent factor associated with significantly decreased risk of sodium level <130 mEq/L (odds ratio, 0.17; 95% confidence interval, 0.08-0.36; P = .000). CONCLUSIONS: Right atrial effluent scavenging was protective against fluctuations in serum sodium levels after crossclamp and Custodiol-HTK cardioplegia administration independently in both entire and matched cohort, and was also associated with decreased incidence of postoperative seizures.
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Soluciones Cardiopléjicas/efectos adversos , Paro Cardíaco Inducido , Hiponatremia , Convulsiones , Soluciones Cardiopléjicas/uso terapéutico , Preescolar , Glucosa/efectos adversos , Glucosa/uso terapéutico , Paro Cardíaco Inducido/efectos adversos , Paro Cardíaco Inducido/métodos , Humanos , Lactante , Manitol/efectos adversos , Manitol/uso terapéutico , Complicaciones Posoperatorias , Cloruro de Potasio/efectos adversos , Cloruro de Potasio/uso terapéutico , Procaína/efectos adversos , Procaína/uso terapéutico , Estudios Retrospectivos , Sodio/sangreRESUMEN
BACKGROUND: For emergent intrapartum cesarean delivery (CD), the literature does not support the use of any particular local anesthetic solution to extend epidural analgesia to cesarean anesthesia. We hypothesized that 3% chloroprocaine (CP) would be noninferior to a mixture of 2% lidocaine, 150 µg of epinephrine, 2 mL of 8.4% bicarbonate, and 100 µg of fentanyl (LEBF) in terms of onset time to surgical anesthesia. METHODS: In this single-center randomized noninferiority trial, adult healthy women undergoing CD were randomly assigned to epidural anesthesia with either CP or LEBF. Sensory blockade (pinprick) to T10 was established before operating room (OR) entry for elective CD. On arrival to the OR, participants received the epidural study medications in a standardized manner to simulate the conversion of "epidural labor analgesia to surgical anesthesia." The primary outcome was the time to loss of touch sensation at the T7 level. A noninferiority margin was set at 3 minutes. The secondary outcome was the need for intraoperative analgesia supplementation. RESULTS: In total, 70 women were enrolled in the study. The mean onset time to achieve a bilateral sensory block to touch at the T7 dermatome level was 655 (standard deviation [SD] = 258) seconds for group CP and 558 (269) seconds for group LEBF, a difference in means of 97 seconds (90% confidence interval [CI], SD = -10.6 to 204; P = .10 for noninferiority). The upper limit of the 90% CI for the mean difference exceeded the prespecified 3-minute noninferiority margin. There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups. CONCLUSION: Both anesthetic solutions have a rapid onset of anesthesia when used to extend low-dose epidural sensory block to surgical anesthesia. Data from the current study provide insufficient evidence to confirm that CP is noninferior to LEBF for rapid epidural extension anesthesia for CD, and further research is required to determine noninferiority.
Asunto(s)
Analgésicos Opioides/uso terapéutico , Anestesia Epidural , Anestesia Obstétrica , Anestésicos Locales/uso terapéutico , Cesárea , Epinefrina/uso terapéutico , Fentanilo/uso terapéutico , Lidocaína/uso terapéutico , Procaína/análogos & derivados , Bicarbonato de Sodio/uso terapéutico , Adulto , Analgesia Epidural , Analgesia Obstétrica , Analgésicos Opioides/efectos adversos , Anestesia Epidural/efectos adversos , Anestesia Obstétrica/efectos adversos , Anestésicos Locales/efectos adversos , Arkansas , Cesárea/efectos adversos , Procedimientos Quirúrgicos Electivos , Epinefrina/efectos adversos , Femenino , Fentanilo/efectos adversos , Humanos , Lidocaína/efectos adversos , Embarazo , Procaína/efectos adversos , Procaína/uso terapéutico , Umbral Sensorial/efectos de los fármacos , Bicarbonato de Sodio/efectos adversos , Factores de Tiempo , Tacto/efectos de los fármacos , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Organ preservation before transplantation is still a challenge. Both the University of Wisconsin and Bretschneider's histidine-tryptophan-ketoglutarate (HTK; Custodiol®) solution are standard for liver, kidney and pancreas preservation. Organ preservation with both solutions is comparable; recently, however, Custodiol® solution has been modified to Custodiol-N according to the needs of today. Thus, our study was defined to study its effect in clinical transplantation. METHODS: Patients undergoing kidney transplantation (n = 412) (including approximately 30 combined kidney-pancreas) or liver transplantation (n = 202) receive grafts that have been cold stored in either Custodiol® or Custodiol-N to demonstrate noninferiority of Custodiol-N regarding both graft function and graft injury after transplantation. DISCUSSION: Preclinical data have clearly shown that Custodiol-N is superior to Custodiol® in cold static organ preservation via mechanisms including inhibition of hypoxic cell injury, cold-induced cell injury and avoidance of adverse effects during warm exposure to the solution. Further clinical safety data on Custodiol-N for cardioplegia are available. Thus, this study was designed to compare Custodiol® with Custodiol-N for the first time in a prospective, randomized, single-blinded, multicentre, phase III clinical transplantation trial. TRIAL REGISTRATION: Eudra-CT, 2017-002198-20. Registered on 28 November 2018.
Asunto(s)
Supervivencia de Injerto/efectos de los fármacos , Trasplante de Riñón , Trasplante de Hígado , Soluciones Preservantes de Órganos/uso terapéutico , Preservación de Órganos , Trasplante de Páncreas , Recolección de Tejidos y Órganos , Austria , Ensayos Clínicos Fase III como Asunto , Glucosa/efectos adversos , Glucosa/uso terapéutico , Humanos , Trasplante de Riñón/efectos adversos , Trasplante de Hígado/efectos adversos , Manitol/efectos adversos , Manitol/uso terapéutico , Estudios Multicéntricos como Asunto , Preservación de Órganos/efectos adversos , Soluciones Preservantes de Órganos/efectos adversos , Trasplante de Páncreas/efectos adversos , Cloruro de Potasio/efectos adversos , Cloruro de Potasio/uso terapéutico , Procaína/efectos adversos , Procaína/uso terapéutico , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Simple Ciego , Factores de Tiempo , Recolección de Tejidos y Órganos/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVE: The present prospective noninferiority randomized trial was designed to demonstrate the safety and efficacy of a single dose of Custodiol histidine-tryptophan-ketoglutarate compared with repetitive cold-blood cardioplegia. METHODS: From October 2012 to May 2014, 110 patients were randomly assigned to 1 of 2 groups: Group 1 (55 patients) received repetitive cold-blood cardioplegia, and group 2 (55 patients) received single-dose Custodiol histidine-tryptophan-ketoglutarate. Isolated aortic valve replacement, isolated mitral valve replacement, and multivalve procedures represented the most frequent operations, with 39 cases (71%) in group 1 and 49 cases (89%) in group 2. There was no difference in cardiopulmonary bypass time (102 ± 26 minutes vs 99 ± 19 minutes, P = .70) or aortic crossclamp time (77 ± 19 minutes vs 74 ± 17 minutes, P = .33). All patients underwent preoperative electrocardiogram and determination of creatine kinase-MB, troponin I, left ventricular ejection fraction, and regional wall motion. Postoperative cardiac biomarkers were checked at 7, 24, and 48 hours, and an echocardiogram was obtained to check for left ventricular function abnormalities. RESULTS: There was no difference in cardiac biomarkers release between the 2 groups at baseline and 7, 24, and 48 hours postoperatively (creatine kinase, P = .18, troponin P = .23). Left ventricular function was similar between groups preoperatively and at 24 hours after surgery. No death or myocardial infarction was observed in either group. There were no differences in intensive care unit length of stay, incidence of atrial fibrillation, use of inotropes or vasopressors support, time of intubation, or creatinine levels. CONCLUSIONS: A single dose of Custodiol histidine-tryptophan-ketoglutarate cardioplegia is not inferior to repeated cold-blood cardioplegia during elective cardiac surgery.
Asunto(s)
Soluciones Cardiopléjicas/administración & dosificación , Paro Cardíaco Inducido/métodos , Corazón/fisiología , Anciano , Soluciones Cardiopléjicas/efectos adversos , Soluciones Cardiopléjicas/uso terapéutico , Forma MB de la Creatina-Quinasa/sangre , Femenino , Glucosa/administración & dosificación , Glucosa/efectos adversos , Glucosa/uso terapéutico , Hemodinámica/fisiología , Humanos , Tiempo de Internación , Masculino , Manitol/administración & dosificación , Manitol/efectos adversos , Manitol/uso terapéutico , Persona de Mediana Edad , Complicaciones Posoperatorias , Cloruro de Potasio/administración & dosificación , Cloruro de Potasio/efectos adversos , Cloruro de Potasio/uso terapéutico , Procaína/administración & dosificación , Procaína/efectos adversos , Procaína/uso terapéutico , Estudios Prospectivos , Troponina I/sangreRESUMEN
BACKGROUND: Single-dose cardioplegia is preferred in minimal invasive mitral valve surgery to maintain the adjustment of the operative site without change of preset visualization. The aim of our study was to compare two widely used crystalloid cardioplegias Bretschneider (Custodiol®) versus St. Thomas 2 in patients who underwent mitral valve repair via small anterolateral right thoracotomy. MATERIAL AND METHODS: From May 2012 until February 2019, 184 isolated mitral valve procedures for mitral valve repair via anterolateral right thoracotomy were performed using Bretschneider (Custodiol®) cardioplegia (n = 123) or St. Thomas (n = 61). Primary efficacy endpoint was peak postoperative high-sensitivity cardiac troponin (hs-cTnT) during hospitalization. Secondary endpoints were peak creatine kinase-muscle brain type (CK-MB) and creatine kinase (CK) as well as safety outcomes. We used inverse probability of treatment weighting (IPTW) in order to adjust for confounding by indication. RESULTS: Peak hs-cTnT was higher after use of Bretschneider (Custodiol®) (geometric mean 716 mg/L, 95% confidence interval (CI) 605-847 mg/L) vs. St. Thomas 2 (561 mg/L, CI 467-674 mg/L, p = 0.047). Peak CK-MB (geometric mean after Bretschneider (Custodiol®): 40 µg/L, CI 35-46, St. Thomas 2: 33 µg/L, CI 27-41, p = 0.295) and CK (geometric mean after Bretschneider (Custodiol®): 1370 U/L, CI 1222-1536, St. Thomas 2: 1152 U/L, CI 972-1366, p = 0.037) showed the same pattern. We did not see any difference with respect to postoperative complications between treatment groups after IPTW. CONCLUSION: Use of St. Thomas 2 cardioplegia was associated with lower postoperative peak levels of all cardiac markers that reflect cardiac ischemia such as hs-cTnT, CK, and CK-MB as compared to Bretschneider (Custodiol®) in propensity-weighted treatment groups.
Asunto(s)
Soluciones Cardiopléjicas/uso terapéutico , Válvula Mitral/efectos de los fármacos , Anciano , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/métodos , Soluciones Cardiopléjicas/efectos adversos , Intervalos de Confianza , Femenino , Glucosa/efectos adversos , Glucosa/uso terapéutico , Corazón/efectos de los fármacos , Humanos , Masculino , Manitol/efectos adversos , Manitol/uso terapéutico , Persona de Mediana Edad , Válvula Mitral/metabolismo , Válvula Mitral/cirugía , Isquemia Miocárdica/metabolismo , Isquemia Miocárdica/prevención & control , Miocardio/metabolismo , Cloruro de Potasio/efectos adversos , Cloruro de Potasio/uso terapéutico , Procaína/efectos adversos , Procaína/uso terapéutico , Toracotomía/métodosRESUMEN
INTRODUCTION: Spinal anesthesia in outpatient urology is controversial (longer hospital stay, risk of urinary retention). The main goal was to evaluate outpatient spinal anesthesia and to compare 2 local anesthetics secondarily. MATERIAL: Monocentric retrospective study including all patients undergoing surgery in urological ambulatory surgery under spinal anesthesia between December 2011 and May 2015, split into two groups according to the local anesthetic used: bupivacaine (BP) and chloroprocaine (CP). Quantitative variables were compared by Student's t-test, qualitative variables by χ2 test. RESULTS: Seventy-one (95%) out of the 75 patients included have been discharged the same day. Discharge was impossible in these cases: patient alone at home (1), bladder clot (1), JJ intolerance (1), delayed micturition (1). The mean duration of the procedure was 27±19min, the SSPI's was 55±31min, the stay's was 360±91min. A total of 45 patients (60%) received BP and 30 (40%) received CP. The mean residence time in SSPI was significantly reduced in the CP group (47±24min vs. 61±34min, P=0.04). One patient experienced urination delay in the BP group with no significant difference. No significant difference for the other criteria studied despite the mean age, which is higher in the CP group (P=0.02). CONCLUSION: Spinal anesthesia is adapted to ambulatory urology, and does not increase the risk of urinary retention, especially with CP that would decrease the length of stay in SSPI compared to BP. LEVEL OF EVIDENCE: 4.