Does Depth of Neuromuscular Blockade (NMB) Affect Surgical Conditions and Postoperative Pain in Obese Patients Undergoing Robotic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Assessment of surgical conditions during deep versus moderate NMB in patients undergoing robotic abdominal surgery
研究概览
简要总结
A prospective, randomized, outcome trial to evaluate, if depth of neuromuscular blockade (NMB) will affect surgical conditions and postoperative pain based on the degree of neuromuscular block during robotic surgery for gynecological and urologic procedures in obese and non-obese patients.
详细描述
Study Procedures:
Anesthesia will be induced with propofol (2 mg/kg), fentanyl (1-2 µg/kg) and rocuronium (0.6 mg/kg) to facilitate intubation. A #8 endotracheal tube in males and #7endotracheal tube in females will be inserted in the trachea and secured at 22 cm. Anesthesia will be maintained with sevoflurane to maintain the BIS value between 40 and 60. Analgesia will be provided with fentanyl at 1-2 µg/kg/h or remifentanil 0.5-2 µg/kg/min. Anesthesia will continue until surgery is completed.
Patients will be randomized to either deep neuromuscular blockade (NMB) or moderate NMB as described below.
Rocuronium will be administered to keep NMB deep or moderate NMB according to the randomization.
Deep NMB: Rocuronium will be given as a continuous infusion for deep block. Train of four (TOF) will be maintained at 0 (zero) with at least one post-tetanic count (PTC). Patients' paralysis will be continued through the anesthesia period. At the end of surgery, deep Block patients' will receive 4 mg/kg sugammadex and the patient's trachea will be extubated according to routine extubation criteria.
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, Investigator, Outcomes Assessor)
盲法说明
Subjects will not be informed to which NMB depth they were randomized to.
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
- •Patients scheduled for elective robotic gynecological or urologic surgery under general anesthesia.
- •Patients are willing and sign an IRB approved consent
- •Patients will be 18 years or older
排除标准
- •Patients with atrial fibrillation
- •Other significant arrhythmia (Lown grade 3 or greater)
- •Patients with aortic regurgitation
- •Unable to receive or refuses to usehydromorphone for pain management post-operatively (allergic, bad experience previously with use)
研究组 & 干预措施
Deep NMB
Deep NMB: Intervention: Rocuronium will be given as a continuous infusion for deep block. TOF will be maintained at 0 (zero) with at least one PTC. Patients' paralysis will be continued through the anesthesia period. At the end of surgery, patients will receive 4 mg/kg sugammadex and the patient's trachea will be extubated according to routine extubation criteria.
干预措施: NMB with rocuronium bromide (Drug)
Moderate NMB
Moderate NMB: Intervention: Rocuronium will be used as bolus doses to achieve a moderate block. TOF will be maintained between 1 to 3 twitches. PTC will not be counted. Paralysis will be continued throughout the anesthesia period. At the end of surgery, patients will receive 2 mg/kg sugammadex and the patient's trachea will be extubated according to routine extubation criteria.
干预措施: NMB with rocuronium bromide (Drug)
结局指标
主要结局
Assessment of surgical conditions during deep versus moderate NMB in patients undergoing robotic abdominal surgery
时间窗: data will be reported every 15 minutes starting post anesthesia induction until the end of general anesthesia
Surgical conditions will be assessed by the Leiden surgical rating scale (Martini BJA 2014; 112:498) as follows: Scale range from 1 to 5 with 1 describing extremely poor conditions and 5 describing optimal conditions for surgery
次要结局
- Assessment of PVI changes to predict fluid responsiveness in robotic surgery(PVI will be measured every 15 minutes and after any fluid bolus. Fluid bolus will be given, when PVI is > 12)
- Incidence of good and optimal surgical conditions in obese and non-obese patients undergoing robotic abdominal surgery(Data will be reported every 15 minutes starting post anesthesia induction until the end of general anesthesia)
- Assessment of postoperative pain after deep versus moderate NMB in patients undergoing robotic abdominal surgery. Does depth of neuromuscular block (NMB) affect postoperative pain ?(First 24 hours postoperatively at time points 1hour, 6 hours after surgery and postoperative day one)
研究者
Rainer Lenhardt
Professor and Vice-Chair Clinical Affairs; Department of Anesthesiology and Perioperative Medicine, MBA
University of Louisville