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

Iuliu Hatieganu University of Medicine and Pharmacy

Status: Enrolling

Conditions: Intraoperative Monitoring

Treatments: Other: Intra-operative analgesia guided by SPI

Study type: Interventional

Funder types: Other

Identifiers

NCT05884229

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Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Standard opioid administration

No Intervention group

SPI-guided opioid administration

Experimental group

Treatment:

Other: Intra-operative analgesia guided by SPI