An interventional study of Sugammadex and Neostigmine in Laparoscopic Bariatric Surgery and Sugammadex, sponsored by Shanxi Bethune Hospital. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Shanxi Bethune Hospital · Not applicable, Interventional, and Treatment
Laparoscopic bariatric surgery has been recognized as the most effective treatment for obesity and related metabolic diseases. Because obesity patients often associated with sleep apnea syndrome or obesity hypoventilation syndrome, combined with the residual effect of muscle relaxants during the operation is easy to lead to respiratory obstruction and respiratory insufficiency, and hypoxemia and carbon dioxide retention are easy to occur after surgery, Post-extubation is prone to upper respiratory tract obstruction such as retrolingual fall, thus increase the risk of perioperative respiratory complications. Therefore, it is very important to achieve a rapid and effective antagonistic muscle relaxant effect, reduce the postoperative muscle relaxation residue, and maintain the patency of the patient's airway.
Compared with the traditional cholinesterase inhibitor neostigmine, sugammadex is a specific antagonist of novel aminosteroid muscle blockers, which rapidly reverses moderate and deep neuromuscular block by combining with rocuronium or vecuronium 1:1,without compatibility with due to its no effect on muscarinic receptors or plasma cholinesterase. The absence of cholinergic and cardiovascular effects during awakening from anesthesia would be significant benefit for patients with cardiovascular or respiratory diseases.
The pharmacological effect of sugammadex is its ability to form a tight 1:1 complex with amino steroid neuromuscular blockers, which causes a lower plasma concentration of free neuromuscular blockers and promotes the transfer of neuromuscular blockers from the peripheral compartment (including the neuromuscular junction) to the plasma gradient. A meta-analysis by Vaghiri et al showed that reversal of neuromuscular block by sugammadex accelerated postoperative recovery of intestinal peristalsis in patients undergoing colorectal surgery compared with acetylcholinesterase inhibitors. Deljou et al confirmed that reversal of neuromuscular blockade with sugammadex shortened the time to first postoperative defecation in patients compared with neostigmine / glononium bromide. The study will investigate the effect of sugammadex in patients undergoing laparoscopic bariatric surgery.
Study design
2.1. Type of the study The research is a single-center, double-blind, randomized-controlled clinical trial.
2.2 Sample size calculation The estimated sample size was calculated using SPSS Statistics, version 26.0 ((IBM Corp), and this was based on our preliminary study.
2.3 Randomization and blinding
Patients were randomly assigned in a 1:1 ratio into 2 groups, the neostigmine group or the sugammadex group via centrally computer-generated group randomization. Immediately after the surgery, a sealed opaque envelope containing the patient group assignment was opened by an experienced anesthesiologist in charge. When T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight), the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight).
Participants in the neostigmine group and sugammadex group were kept blinded to their group assignment. This study involved researchers who conducted the postoperative follow-up and evaluation (blinded) and researchers who administered the treatment (unblinded). The unblinded researchers who administered the interventions were not involved in the evaluation of the postoperative outcomes.
Quality control
All research data, both in paper and electronic formats, will be kept for at least 5 years. If readers have any questions after the article\'s publication, they may contact the corresponding author for access to the original data. Patient information will remain anonymous, including name, ID number and telephone number. All data related to enrolled patients collected during the study period of this project will be archived and safeguarded, and all study members and study sponsors are asked to keep subject information confidential. The study protocol will be reviewed and revised by statistical experts. Investigators will adhere to pre-defined standard operating procedures, encompassing patient screening, follow-up standardization, result assessment, and data management. The Ethics Committee of Shanxi Bethune Hospital will review the trial every six months.
Statistical analysis was performed using SPSS Statistics, version 26.0. Normally distributed continuous variables were presented as mean (SD) values, and intergroup comparisons used independent-sample t-test. Nonnormally distributed variables were presented as median (IQR) values, and intergroup comparisons were determined using the Mann-Whitney test. Categorical variables were expressed as frequencies and percentages, and these were compared using either the χ2 test or the Fisher exact test. A P\<0.05 was considered to be statistically significant.
Shanxi Bethune Hospital is the lead sponsor of 23 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
When T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight)
Drug: Sugammadex
When T2 appeared, the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight).
Drug: Neostigmine
When T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight), the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight).
When T2 appeared, the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight).
Postoperative muscle relaxation recovery
Postoperative muscle relaxation recovery, measured using the time of train-of-four stimulation (TOF) ratio ≥0.9
Time frame: After injection of muscle relaxation antagonist, an average of 30 minutes
Postoperative pain scores at rest and during coughing
Pain scores, measured using the Visual Analog Scale(0 points indicated no pain, a score \<4 indicated mild pain; a 4-7 score indicated moderate pain, a score \>7 points indicated severe pain, and a score of 10 indicated unbearably severe pain)
Time frame: 1, 6, 12, 24 and 48 hours after surgery
Postoperative opioid consumption
The total amount of sufentanil used in the PCA pump within the initial 48 hours postoperatively
Time frame: 48 hours after surgery
Postoperative remedial analgesia rate
The rate of remedial analgesia 48 hours postoperatively
Time frame: 48 hours after surgery
Postoperative arterial blood gas
PaO2 and PaCO2, measured using the blood-gas analyzer
Time frame: 12, 24 and 48 hours after surgery
Postoperative pulmonary function
Forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) and interstitial forced expiratory flow 25%-75%(FEF25%-75%) are measured using the pulmonary function testing equipment.
Time frame: 12, 24 and 48 hours after surgery
Postoperative gastrointestinal function
I-FEED scores(an I-FEED scores of 0-2 indicates postoperative gastrointestinal normality, 3-5 indicates postoperative gastrointestinal intolerance, and ≥6 indicates postoperative gastrointestinal dysfunction)
Time frame: 12, 24 and 48 hours after surgery
The time of first exhaust and defecation
The time of first flatus and defecation within 48h after operation was measured by hour
Time frame: 48 hours after surgery
Postoperative recovery quality
Quality of recovery, measured using the 15-item Quality of Recovery questionnaire (QoR-15), It ranges from 0 to 150, with a higher score indicating a better quality of recovery
Time frame: 24 and 48 hours after suegery
No study locations are listed for this record.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sugammadex
Shanxi Bethune Hospital