Laparoscopic Bariatric Surgery: Impact of the Level of Neuromuscular Blockade on Surgical Conditions - Comparison Between Moderate and Deep Neuromuscular Blockade
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Improvement of surgical conditions
研究概览
简要总结
The purpose of this study is to determine whether deep neuromuscular blockade compared to moderate neuromuscular blockade may improve the surgical conditions in patients undergoing laparoscopic bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient between 18 and 64 years
- •indication for bariatric surgery accordingly to HAS
- •patient undergoing laparoscopic or robotic gastric bypass surgery
- •written informed consent
- •affiliation to social security
- •Non-inclusion Criteria:
- •known hypersensibility to any of the drugs used during this study
- •absence of written informed consent
排除标准
- 未提供
研究组 & 干预措施
Moderate rocuronium neuromuscular blockade
rocuronium bolus is given if needed to maintain moderate neuromuscular blockade (TOF-count 2-4) during gastrojejunal anastomosis
干预措施: rocuronium (Drug)
deep rocuronium neuromuscular blockade
rocuronium bolus is given if needed to maintain deep neuromuscular blockade (here defined as a Posttetanic Count 1 - 5) during gastrojejunal anastomosis
干预措施: rocuronium (Drug)
结局指标
主要结局
Improvement of surgical conditions
时间窗: 15 minutes
The surgical conditions will be evaluated with the King Score (M. King et al Anesthesiology 2000; 93: 1392 - 97). This score is a 4-point score. The evaluation will be done by the surgeon who is blinded. An improvement of at least 1-point will be considered as clinical relevant.
次要结局
- Pneumoperitoneum generated pressure(15 minutes)