Effect of Neuromuscular Blockade Protocol on Perioperative Outcomes of Robotic Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 192
- 主要终点
- incidence of postoperative major respiratory complications
研究概览
简要总结
During robotic laparoscopic surgery, a high intraperitoneal pressure may result in high airway pressure and inadequate perfusion of the abdominal organs, and as a result the postoperative outcomes. Degree of neuromuscular blockade (NMB) can affect the intraperitoneal pressure. In this study, the patients undergoing robotic laparoscopic surgery will be assigned to deep NMB group and moderate NMB group. Perioperative outcomes including maximal intraperitoneal pressure, maximal intraoptic pressure, quality of emergence, postoperative pain, and incidence of postoperative respiratory complication will be compared. The results of this study will provide evidence for optimizing NMB protocol of robotic laparoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Muscle relaxant will be given by a specific investigator that is not involved in anesthesia and outcome assessment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for elective robotic laparoscopic surgery under general anesthesia
- •American Society of Anesthesiologists status 1-2
- •Body mass index of 18-30kg/m2
- •Patients scheduled to be positioned in trendelenburg position during surgery
排除标准
- •Patients allergic to rocuronium
- •Patients with neuromuscular dysfunction
- •Patients with existed pulmonary diseases
- •Patients with hepatic or renal dysfunction
研究组 & 干预措施
deep neuromuscular blockade
Rocuronium, a neuromuscular blocking agent will be given by continuous infusion at a dose that reaction to train of four (TOF) stimulation is depressed to zero
干预措施: Rocuronium (Drug)
deep neuromuscular blockade
Rocuronium, a neuromuscular blocking agent will be given by continuous infusion at a dose that reaction to train of four (TOF) stimulation is depressed to zero
干预措施: continuous infusion (Other)
moderate neuromuscular blockade
Rocuronium, a neuromuscular blocking agent will be given at a dose by intermittent injection that reaction to train of four (TOF) stimulation is kept 1 to 2
干预措施: Rocuronium (Drug)
moderate neuromuscular blockade
Rocuronium, a neuromuscular blocking agent will be given at a dose by intermittent injection that reaction to train of four (TOF) stimulation is kept 1 to 2
干预措施: intermittent injection (Other)
结局指标
主要结局
incidence of postoperative major respiratory complications
时间窗: from end of surgery to discharge, at an average of 4 days
incidence of pneumonia and atelectasis
次要结局
- satisfaction score of the patients(from end of surgery to discharge,at an average of 4 days)
- number of surgeon asking for improving muscle relax(from start of surgery to end of surgery, at an average of 3.5 hours)
- incidence of shoulder pain in 24 hours after surgery(from end of surgery to 24 hours after surgery)
- time to extubation(from end of sevoflurane inhalation to extubation, at an average of 20 minutes)
- incidence of nausea and vomiting in post-anesthesia care unit(from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes)
- incidence of residual neuromuscular blockade in the post-anesthesia care unit(from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes)
- maximal airway pressure(from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours)
- minimal cerebral oxygen saturation(from start of surgery to end of surgery, at an average of 3.5 hours)
- maximal intraocular pressure(from start of surgery to end of surgery, at an average of 3.5 hours)
- visual analogue scale at 24 hours after surgery(end of surgery to 24 hours after surgery)
- expense after surgery(end of the surgery to discharge,at an average of 4 days)
研究者
Zhihong LU
principle investigator
Air Force Military Medical University, China