Effect of Sugammadex on Quality of Recovery Following Laparoscopic Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Postoperative muscle relaxation recovery
研究概览
简要总结
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.
详细描述
- Study purpose This study intends to compare the neuromuscular block effects of sugammadex or neostigmine against rocuronium after laparoscopic bariatric surgery, investigate the effect of sugammadex reversing neuromuscular block on the recovery quality of laparoscopic bariatric surgery by observing the time from muscle relaxation antagonism to TOF ratio ≥0.9, tracheal extubation time, postoperative Richmond Agitation-Sedation Scale, postoperative Visual Analogue Scale and opioid consumption, postoperative respiratory and gastrointestinal function, postoperative QoR-15 recovery quality score and other indicators, to provide clinical data for rapid recovery of 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-50 years
- •Body Mass Index (BMI) ≥ 40kg/m²
- •American Society of Anesthesiologists (ASA) grade I to III classification
- •NYHA cardiac function grade I - II
排除标准
- •Patients with neuromuscular disease or respiratory system disease
- •Patients with severe abnormal liver and renal function
- •Perioperative use of drugs known to interact with rocuronium
- •Patients with unstable mental illness or refusal to participate
研究组 & 干预措施
Sugammadex group
When T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight)
干预措施: Sugammadex (Drug)
Neostigmine group
When T2 appeared, the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight).
干预措施: Neostigmine (Drug)
结局指标
主要结局
Postoperative muscle relaxation recovery
时间窗: After injection of muscle relaxation antagonist, an average of 30 minutes
Postoperative muscle relaxation recovery, measured using the time of train-of-four stimulation (TOF) ratio ≥0.9
次要结局
- Postoperative pain scores at rest and during coughing(1, 6, 12, 24 and 48 hours after surgery)
- Postoperative opioid consumption(48 hours after surgery)
- Postoperative remedial analgesia rate(48 hours after surgery)
- Postoperative arterial blood gas(12, 24 and 48 hours after surgery)
- Postoperative pulmonary function(12, 24 and 48 hours after surgery)
- Postoperative gastrointestinal function(12, 24 and 48 hours after surgery)
- The time of first exhaust and defecation(48 hours after surgery)
- Postoperative recovery quality(24 and 48 hours after suegery)