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

NCT05884229 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-01-01
Completion
2024-01-01

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05884229 on ClinicalTrials.gov