The Effect of SPI (Surgical Pleth Index) - Guided Anaesthesia Versus Conventional Analgesia on Opioid Consumption Under Multimodal Analgesia in Gastric Sleeve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain scores on the visual analog scale during the first 90 minutes post-operatively
研究概览
简要总结
This is a unicentric, prospective randomised trial that aims to evaluate the role of intra-operative monitoring of nociception through SPI (Surgical Pleth Index) in guiding analgesia and reducing opioid consumption in obese patients undergoing bariatric surgery.
We aim to enrol 40 patients having laparoscopic gastric sleeve surgery in the Cluj-Napoca County Hospital. They will be randomised into two groups, one with opioid administration during surgery guided by SPI, and the other one guided by anesthetist experience. We will monitor opioid consumption, pain scores during the first 90 minutes post-operatively, hemodinamic events during surgery and the duration between reversal of neuromuscular block and extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled to laparoscopic gastric sleeve surgery in First Surgical Clinic, Cluj-Napoca County Hospital
排除标准
- •drugs that affect the autonomic nervous system
- •peripheral neuropathy
- •altered renal/hepatic function
- •chronic opioid use
- •use of vaso-active drugs intra-operatively
结局指标
主要结局
Pain scores on the visual analog scale during the first 90 minutes post-operatively
时间窗: during the first 90 minutes post-operatively
Pain scores on the visual analog scale during the first 90 minutes post-operatively
次要结局
- Rescue analgesia(in the first 90 minutes post-operatively)
- Opioid consumption(during surgery)
- Hemodinamic events(during surgery)
- Sevoflurane concentration(during surgery)
- Time from neuromuscular reversal to extubation(at the end of surgery)
研究者
Leahu Crina
MD
Iuliu Hatieganu University of Medicine and Pharmacy