A Prospective Randomized Clinical Trial Evaluating Surgical Conditions During Laparoscopic Bariatric Surgery With Deep Versus Moderate Neuromuscular Blockade
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Surgeon Satisfaction Scale
研究概览
简要总结
Obesity affects more than 78 million adults in the United States and it is estimated that 35% of the US population is obese. Currently, more than 179,000 bariatric procedures are performed in the US each year with the majority of these surgeries using laparoscopic techniques. Surgeons often request deep neuromuscular blockade (NMB) during surgery, but there is no evidence that a deep NMB improves surgical conditions and that the surgeons can discriminate between a moderate and deep NMB. There is also evidence that maintaining low insufflation pressures during laparoscopic surgery may decrease postoperative pain. The goal of this prospective, randomized, assessor-blinded controlled trial is to test the hypothesis that deep NMB provides optimal surgical conditions during laparoscopic bariatric surgery in the morbidly obese patient. It will also determine if deep NMB allows the surgeon to utilize lower insufflation pressure and decreases postoperative pain requirements after laparoscopic bariatric surgery.
详细描述
Subjects will be randomized to one of four groups:
- moderate neuromuscular block (NMB) + 10 mm insufflation pressure (IP);
- moderate NMB + 15 mm IP;
- deep NMB + 10 mm IP; or
- deep NMB + 15 mm IP.
A moderate NMB block will be defined as 2-3 twitches in the train of four (TOF) and a deep NMB will be defined as 0-1 posttetanic count. The surgeons will be asked to rate their satisfaction with the surgical conditions using a five-point ordinal scale ranging from 1 (extremely poor) to 5 (optimal conditions). The first rating will occur at the beginning of the procedure when the NMB level is stable at either a deep or moderate block and the intra-abdominal pressure is either 10 or 15 mm Hg (per randomization). The surgeon will be blinded to the insufflation pressure at this point. If the surgical conditions are rated as extremely poor or poor, the level of the neuromuscular block can be increased and/or the insufflation pressure can be increased to 15 mm Hg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •ASA I-III
排除标准
- •Inability to obtain written informed consent
- •Pregnancy or breastfeeding
- •Allergy to rocuronium, sugammadex, or any anesthetic agents used in the protocol
- •Known or suspected neuromuscular disorders
- •Significant renal disease with a serum creatinine ≥ 2 mg/dl f. Significant liver disease g. A family history of malignant hyperthermia
研究组 & 干预措施
moderate NMB + 10 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
干预措施: Rocuronium (Drug)
moderate NMB + 10 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
干预措施: Insufflation pressure (Device)
moderate NMB + 15 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.
干预措施: Rocuronium (Drug)
moderate NMB + 15 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.
干预措施: Insufflation pressure (Device)
deep NMB + 10 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
干预措施: Rocuronium (Drug)
deep NMB + 10 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
干预措施: Insufflation pressure (Device)
deep NMB + 15 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
干预措施: Rocuronium (Drug)
deep NMB + 15 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
干预措施: Insufflation pressure (Device)
结局指标
主要结局
Surgeon Satisfaction Scale
时间窗: day of surgery
The surgeon will grade his satisfaction with the surgical conditions using a 5 point scale with 1 - extremely poor; 2 - poor; 3 - acceptable; 4. good; 5 - optimal surgical conditions
次要结局
- Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure(day of surgery)
- Postoperative Opioid Requirement(day of surgery until hospital discharge (approximately 2-3 days))
研究者
Terri Monk
Professor, Anesthesiology
University of Missouri-Columbia