The Effect of SPI (Surgical Pleth Index) - Guided Anaesthesia on Opioid Consumption in Gastric Sleeve Surgery

Not Applicable

Recruiting

• Conditions: Intraoperative Monitoring
• Interventions: Other: Intra-operative analgesia guided by SPI

• Registration Number: NCT05884229
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Last Update Submitted: 2023-05-22
• Study First Posted: 2023-06-01
• Last Update Posted: 2023-06-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPI-guided opioid administration	Intra-operative analgesia guided by SPI	-

Primary Outcome Measures

Name	Time	Method
Pain scores on the visual analog scale during the first 90 minutes post-operatively	during the first 90 minutes post-operatively	Pain scores on the visual analog scale during the first 90 minutes post-operatively

Secondary Outcome Measures

Name	Time	Method
Rescue analgesia	in the first 90 minutes post-operatively	the need for rescue opioids during the first 90 minutes post-operatively
Opioid consumption	during surgery	the amount of fentanyl per LBW
Hemodinamic events	during surgery	an increase in heart rate or mean arterial pressure with more than 20% of the basal values (measured on the ward)
Sevoflurane concentration	during surgery	mean MAC and sevoflurane concentration during surgery
Time from neuromuscular reversal to extubation	at the end of surgery	Time from neuromuscular reversal to extubation

Trial Locations

Locations (1)

First Surgical Clinic, County Hospital; 🇷🇴 Cluj-Napoca, Romania