Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Surgical Rating
研究概览
简要总结
This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.
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
- Triple (Participant, Care Provider, Investigator)
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
- •ASA I-III
- •BMI > 34 kg/m2
- •Elective bariatric surgery.
排除标准
- •Known or suspected neuromuscular disorders impairing neuromuscular function
- •Allergies to muscle relaxants, anesthetics or narcotics
- •A(family) history of malignant hyperthermia
- •Women who are or may be pregnant or are currently breast feeding
- •Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.
研究组 & 干预措施
moderate neuromuscular block
rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
干预措施: Rocuronium (Drug)
deep neuromuscular block
rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
干预措施: Rocuronium (Drug)
结局指标
主要结局
Surgical Rating
时间窗: intraoperative
During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. The rating scale will be averaged for each subject and the mean values will be reported.
次要结局
- Extubation(intraoperative)
- Pain(postoperative, for up to 2 hours)
- Respiration(2 hours postoperative)
- Mean Arterial Blood Pressure(2 hours postoperative)
研究者
Albert Dahan
MD, PhD, professor
Leiden University Medical Center