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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Intraoperative Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard opioid administration

Group Type NO_INTERVENTION

No interventions assigned to this group

SPI-guided opioid administration

Group Type EXPERIMENTAL

Intra-operative analgesia guided by SPI

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No