Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia With Rocuronium: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean paired difference in TOF ratio (AMG vs EMG)
研究概览
简要总结
The goal of this prospective observational study is to compare two different methods of monitoring muscle relaxation during anesthesia - acceleromyography (AMG) and electromyography (EMG) - in people with obesity who are having bariatric surgery with general anesthesia and the muscle relaxant rocuronium.
The main question is: Which method is more accurate and precise in measuring the Train-of-Four (TOF) ratio during surgery? As part of this comparison, researchers will also note how quickly each method detects recovery of muscle function after the reversal drug sugammadex.
Participants will:
- Receive standard anesthesia care for bariatric surgery, including rocuronium to relax the muscles.
- Have two small monitoring devices applied, one to each hand: AMG on one hand, EMG on the other.
- Be monitored for muscle function during surgery and after receiving sugammadex to reverse the muscle relaxation.
Researchers will also record how easy each device is to use and whether participants have any breathing problems after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years
- •Pathological obesity (Class II with comorbidities or Class III)
- •Scheduled for bariatric surgery under general anesthesia
- •Written informed consent obtained
排除标准
- •Severe acute or chronic respiratory disease (e.g., asthma, COPD, severe restrictive disease)
- •Severe acute or recent cardiac disease (e.g., acute or recent myocardial infarction, inducible ischemia, heart failure)
- •End-stage hepatic or renal disease
- •Intolerance, allergy, or contraindication to study-related drugs
- •Absence of informed consent
结局指标
主要结局
Mean paired difference in TOF ratio (AMG vs EMG)
时间窗: Intraoperative period
Mean difference between acceleromyography (AMG) and electromyography (EMG) measurements of the Train-of-Four (TOF) ratio (unitless) obtained from paired intraoperative recordings.
次要结局
- Time to optimal conditions for tracheal intubation(From rocuronium administration to tracheal intubation (approximately 1-3 minutes).)
- Maintenance of deep neuromuscular block(From induction of anesthesia to start of reversal with sugammadex (approximately 60-120 minutes))
- Usability and quality assessment of AMG and EMG monitoring(At the end of anesthesia (single assessment).)
- Perioperative changes in heart rate(From induction of anesthesia through PACU discharge.)
- Time to recovery of TOF ratio ≥ 0.9 after sugammadex(From administration of sugammadex to achievement of TOF ratio ≥ 0.9 (typically 1-5 minutes).)
- Perioperative changes in mean arterial pressure(From induction of anesthesia through PACU discharge)
- Incidence of postoperative respiratory complications(Through PACU discharge (approximately 1-2 hours after surgery).)
- Perioperative changes in oxygen saturation (SpO₂)(From induction of anesthesia through PACU discharge)
- Perioperative changes in perfusion index(From induction of anesthesia through PACU discharge.)