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NCT05884229

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

Status unknown NA Last updated 1 June 2023
What this trial tests

NA trial testing Intra-operative analgesia guided by SPI in Intraoperative Monitoring in 40 participants. Status unknown.

Timeline
1 January 2023
Primary endpoint
1 January 2024
1 January 2024

Quick facts

Lead sponsorIuliu Hatieganu University of Medicine and Pharmacy
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment40
Start date1 January 2023
Primary completion1 January 2024
Estimated completion1 January 2024
Sites1 location across Romania

Drugs / interventions tested

Conditions studied

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Who can join

Adults 18 to 65, any sex, with Intraoperative Monitoring. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Influence of Surgical Pleth Index-Guided Versus Conventional Analgesia on Opioid Consumption During Gastric Sleeve Surgery: A Pilot Study.
    Leahu CE, Petrisor C, Cocu S, Boldis AM, et al · · 2025 · PMID 41157243 · DOI 10.3390/life15101570

Verify or expand the search:

Other recruiting trials for Intraoperative Monitoring

Currently open trials in the same condition.

Other Iuliu Hatieganu University of Medicine and Pharmacy trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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