The Effect of SPI (Surgical Pleth Index) - Guided Anaesthesia Versus Conventional Analgesia on Opioid Consumption Under Multimodal Analgesia in Gastric Sleeve Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intraoperative Monitoring
- Sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pain scores on the visual analog scale during the first 90 minutes post-operatively
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Leahu Crina
MD
Iuliu Hatieganu University of Medicine and Pharmacy
Eligibility Criteria
Inclusion Criteria
- •patients scheduled to laparoscopic gastric sleeve surgery in First Surgical Clinic, Cluj-Napoca County Hospital
Exclusion Criteria
- •drugs that affect the autonomic nervous system
- •peripheral neuropathy
- •altered renal/hepatic function
- •chronic opioid use
- •use of vaso-active drugs intra-operatively
Outcomes
Primary Outcomes
Pain scores on the visual analog scale during the first 90 minutes post-operatively
Time Frame: during the first 90 minutes post-operatively
Pain scores on the visual analog scale during the first 90 minutes post-operatively
Secondary Outcomes
- 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)