Dataset Information

Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial.

ABSTRACT: Residual neuromuscular blockade (NMB) is an important and modifiable factor associated with prolonged mechanical ventilation after cardiac surgery. Studies evaluating the use of sugammadex for residual NMB reversal in the post-cardiac surgery ICU setting are lacking. We conducted a randomized trial to determine the efficacy of sugammadex in reducing time to extubation in patients admitted to the ICU after cardiac surgery.

Design

Single-center, randomized, double-blind, placebo-controlled trial.

Setting

University-based cardiothoracic ICU.

Subjects

Patients (n = 90) undergoing elective aortic valve replacement (AVR) and/or coronary artery bypass grafting (CABG) surgery.

Interventions

Participants were randomized to receive either sugammadex (2 mg/kg) or placebo after arrival to the ICU.

Measurements and main results

The primary study endpoint was time from study drug administration to extubation. Of the 90 patients included in the study (45 in each group), a total of 68 patients underwent CABG, 13 AVR, and nine combined AVR and CABG. Baseline characteristics and intraoperative anesthetic medications were comparable between groups. Patients in sugammadex group had reduced time to extubation compared with the placebo group (median [interquartile range (IQR)]-sugammadex group: 126.0 min [84.0-274.0 min] vs placebo: 219.0 min [121.0-323.0 min]; difference in means [95% CI], 72.8 [1.5-144.1 min]; p = 0.01. There were no differences in negative inspiratory force (mean [sd]-sugammadex group: 33.79 cm H₂O [8.39 cm H₂O] vs placebo: -31.11 cm H₂O [7.17 cm H₂O]) and vital capacity (median [IQR]-sugammadex group: 1.1 L [0.9-1.3 L] vs placebo: 1.0 L [0.9-1.2 L]). There were no differences between groups in postoperative blood product requirement, dysrhythmias, length of ICU, or hospital stay. There were no serious adverse events in either group.

Conclusions

This randomized trial showed that the administration of sugammadex after cardiac surgery decreased time to extubation by approximately 1 hour. Larger trials may be required to confirm these findings and determine the clinical implications.

SUBMITTER: Bardia A

PROVIDER: S-EPMC9788969 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial.

Bardia Amit A Treggiari Miriam M MM Dai Feng F Johnson Chanel C Singh Manila M Kunze Kim K Tickoo Mayanka M Tantawy Hossam H Giersson Arnar A Darr Umer U Schonberger Robert B RB

Critical care explorations 20221222 12

Residual neuromuscular blockade (NMB) is an important and modifiable factor associated with prolonged mechanical ventilation after cardiac surgery. Studies evaluating the use of sugammadex for residual NMB reversal in the post-cardiac surgery ICU setting are lacking. We conducted a randomized trial to determine the efficacy of sugammadex in reducing time to extubation in patients admitted to the ICU after cardiac surgery.<h4>Design</h4>Single-center, randomized, double-blind, placebo-controlled ...[more]

PMID: 36601562

Similar Datasets

Project description:ObjectivesEarly extubation following pediatric cardiac surgery is common, but debate exists whether location affects outcome, with some centers performing routine early extubations in the operating room (odds ratio) and others in the cardiac ICU. We aimed to define early extubation practice variation across hospitals and assess impact of location on hospital length-of-stay and other outcomes.DesignSecondary analysis of the Pediatric Cardiac Critical Care Consortium registry.SettingTwenty-eight Pediatric Cardiac Critical Care Consortium hospitals.PatientsPatients undergoing Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery mortality category 1-3 operations between August 2014 and February 2018.InterventionsNone.Measurements and main resultsWe defined early extubation as extubation less than 6 hours after postoperative admission. Hospitals were categorized based on the proportion of their early extubation patients who underwent an odds ratio extubation. Categories included low- (< 50% of early extubation, n = 12), medium- (50%-90%, n = 8), or high- (> 90%, n = 8) frequency odds ratio early extubation centers. The primary outcome of interest was postoperative hospital length-of-stay. We analyzed 16,594 operations (9,143 early extubation, 55%). Rates of early extubation ranged from 16% to 100% across hospitals. Odds ratio early extubation rates varied from 16% to 99%. Patient characteristics were similar across hospital odds ratio early extubation categories. Early extubation rates paralleled the hospital odds ratio early extubation rates-77% patients underwent early extubation at high-frequency odds ratio extubation centers compared with 39% at low-frequency odds ratio extubation centers (p < 0.001). High- and low-frequency odds ratio early extubation hospitals had similar length-of-stay, cardiac arrest rates, and low mortality. However, high-frequency odds ratio early extubation hospitals used more noninvasive ventilation than low-frequency hospitals (15% vs. 9%; p < 0.01), but had fewer extubation failures (3.6% vs. 4.5%; p = 0.02).ConclusionsConsiderable variability exists in early extubation practices after low- and moderate-complexity pediatric cardiac surgery. In this patient population, hospital length-of-stay did not differ significantly between centers with different early extubation strategies based on location or frequency.

Project description:BackgroundSuccessful weaning and extubation after cardiac surgery is an important step of postoperative recovery. Delayed extubation is associated with poor prognosis and high mortality, thereby contributing to a substantial economic burden. The aim of this study was to develop and validate a prediction model estimate the risk of delayed extubation after cardiac surgery based on perioperative risk factors.MethodsWe performed a retrospective cohort study of adult patients undergoing cardiac surgery from 2014 to 2019. Eligible participants were randomly assigned into the development and validation cohorts, with a ratio of 7:3. Variables were selected using least absolute shrinkage and selection operator (LASSO) logistic regression model with 10-fold cross-validation. Multivariable logistic regression was applied to develop a predictive model by introducing the predictors selected from the LASSO regression. Receiver operating characteristic (ROC) curve, calibration plot, decision curve analysis (DCA) and clinical impact curve were used to evaluate the performance of the predictive risk score model.ResultsAmong the 3,919 adults included in our study, 533 patients (13.6%) experienced delayed extubation. The median ventilation time was 68 h in the group with delayed extubation and 21 h in the group without delayed extubation. A predictive scoring system was derived based on 10 identified risk factors based on 10 identified risk factors including age, BMI ≥ 28 kg/m2, EF < 50%, history of cardiac surgery, type of operation, emergency surgery, CPB ≥ 120 min, duration of surgery, IABP and eGFR < 60 mL/min/1.73 m2. According to the scoring system, the patients were classified into three risk intervals: low, medium and high risk. The model performed well in the validation set with AUC of 0.782 and a non-significant p-value of 0.901 in the Hosmer-Lemeshow test. The DCA curve and clinical impact curve showed a good clinical utility of this model.ConclusionsWe developed and validated a prediction score model to predict the risk of delayed extubation after cardiac surgery, which may help identify high-risk patients to target with potential preventive measures.

Project description:ObjectivesExpedient extubation after cardiac surgery has been associated with improved outcomes, leading to postoperative extubation frequently during overnight hours. However, recent evidence in a mixed medical-surgical intensive care unit population demonstrated worse outcomes with overnight extubation. This study investigated the impact of overnight extubation in a statewide, multicenter Society of Thoracic Surgeons database.MethodsRecords from 39,812 patients undergoing coronary artery bypass grafting or valve operations (2008-2016) and extubated within 24 hours were stratified according to extubation time between 06:00 and 18:00 (day) or between 18:00 and 6:00 (overnight). Outcomes including reintubation, mortality, and composite morbidity-mortality were evaluated using hierarchical regression models adjusted for Society of Thoracic Surgeons predictive risk scores. To further analyze extubation during the night, a subanalysis stratified patients into 3 groups: 06:00 to 18:00, 18:00 to 24:00, and 24:00 to 06:00.ResultsA total of 20,758 patients were extubated overnight (52.1%) and were slightly older (median age 66 vs 65 years, P < .001) with a longer duration of ventilation (4 vs 7 hours, P < .001). Day and overnight extubation were associated with equivalent operative mortality (1.7% vs 1.7%, P = .880), reintubation (3.7% vs 3.4%, P = .141), and composite morbidity-mortality (8.2% vs 8.0%, P = .314). After risk adjustment, overnight extubation was not associated with any difference in reintubation, mortality, or composite morbidity-mortality. On subanalysis, those extubated between 24:00 and 06:00 exhibited increased composite morbidity-mortality (odds ratio, 1.18; P = .001) but no difference in reintubation or mortality.ConclusionsExtubation overnight was not associated with increased mortality or reintubation. These results suggest that in the appropriate clinical setting, it is safe to routinely extubate cardiac surgery patients overnight.

Project description:BackgroundMultiple studies have demonstrated that cardiac resynchronization therapy (CRT) effectively improves the prognosis of heart failure. CRT has been proven to improve patients' quality of life and reduce the risk of readmission and death in selected patients. Nevertheless, a notable proportion of individuals undergoing CRT showed no response. Therefore, we conducted this study to describe CRT characteristics and reported the outcomes 1 year after discharge in Vietnam, along with predictors of non-response to CRT.MethodsThis was a multicenter, ambispective cohort study that enrolled all CRT implantation patients at five hospitals in Ho Chi Minh City: University Medical Center Ho Chi Minh City, Heart Institute of Ho Chi Minh City, Tam Duc Heart Hospital, Thong Nhat Hospital, and Vinmec Central Park Hospital. All patients received treatment according to established guidelines and were monitored for up to 1 year after being discharged. Primary outcomes included rehospitalization and mortality rate 1 year after discharge. Secondary outcomes included early and late complications related to the procedure.ResultsBetween April 2016 and April 2020, 88 cases of successful CRT implantation from five hospitals were enrolled. The majority of the population was male (68.2%), mean age was 62.5±13.4 years old, New York Heart Association (NYHA) III/IV at admission (98.9%), and the mean left ventricular ejection fraction (LVEF) was 24%±5.9%. The incidence of early complications was 9.1%. The overall mortality rate was 12.5%, with 6.8% occurring within the 1-year follow-up period. The population experienced a significant decrease in readmission rate within 1 year after discharge (P=0.001). Additionally, there was a notable improvement in the NYHA function (P<0.001) and an enhancement in the quality of life (P=0.001). Five characteristics correlated with the lack of response to CRT were history of dobutamine usage, QRS interval (QRS) length before implantation, severe ventricular arrhythmias before implantation, atrial fibrillation after implantation, and severe ventricular arrhythmias after implantation.ConclusionsProperly used CRT device improves heart failure symptoms, mortality, and readmissions. There are several predictors of cardiac resynchronization treatment failure. This information helps us comprehend the restricted patient group and develop better treatments, especially in low-income countries.

Dataset Information

Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial.

Design

Setting

Subjects

Interventions

Measurements and main results

Conclusions

Publications

Efficacy and Safety of Sugammadex to Shorten Time-to-Extubation Following Cardiac Surgery: A Single-Center Randomized Placebo-Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets