NCT05884229

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

The Effect of SPI (Surgical Pleth Index) - Guided Anaesthesia Versus Conventional Analgesia on Opioid Consumption Under Multimodal Analgesia in Gastric Sleeve Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intraoperative Monitoring

Interventions

Type	Name	Description
OTHER	Intra-operative analgesia guided by SPI	In the SPI-guided group, when SPI is higher than 50 for the first time and for more than 3 minutes, we will administer 1,0 μg/kg of fentanyl LBW. When SPI is again higher than 50 and for more than 5 minutes, we will re-administer 1,0 μg/kg of fentanyl LBW. We will repeat until SPI is between 20-50.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2023-06-01
• Last updated: 2023-06-01

Locations

1 site across 1 country: Romania