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

Study Overview
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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.

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

Conditions
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Intraoperative Monitoring

Intervention / Treatment
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* Other: Intra-operative analgesia guided by SPI


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard opioid administration<br> | |
| Experimental: SPI-guided opioid administration<br> | Other: Intra-operative analgesia guided by SPI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on the visual analog scale during the first 90 minutes post-operatively | Pain scores on the visual analog scale during the first 90 minutes post-operatively | during the first 90 minutes post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | the amount of fentanyl per LBW | during surgery | 
| Sevoflurane concentration | mean MAC and sevoflurane concentration during surgery | during surgery | 
| Time from neuromuscular reversal to extubation | Time from neuromuscular reversal to extubation | at the end of surgery | 
| Hemodinamic events | an increase in heart rate or mean arterial pressure with more than 20% of the basal values (measured on the ward) | during surgery | 
| Rescue analgesia | the need for rescue opioids during the first 90 minutes post-operatively | in the first 90 minutes post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nociception monitoring, SPI, opioid consumption, gastric sleeve, analgesia