Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids

NCT05752799 | Recruiting

• 1 other identifier: 31235/1.12.2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare Opioid Free and Opioid Based Anaesthesia in patients undergoing sleeve gastrectomy. The main questions it aims to answer are:

• Will the total dose of intraoperative opioid be reduced?
• Will there be difference in pain scores between groups? Participants will be managed with the Nociceptive Level Index algorithm to guide intraoperative analgesia. The Opioid Free Anaesthesia Group will be administered the Multimix infusion (Magnesium sulfate, dexmedetomidine, ketamine). The Opioid Based Anaesthesia Group will receive fentanyl as a bolus dose and remifentanil infusion. Rescue fentanyl bolused will be injected as appropriate according to nociceptive level (NOL) values.

Conditions

Opioid Use, Unspecified; Bariatric Surgery Candidate

Keywords

morbid obesity; opioid free anaesthesia; nociception level; analgesia; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative Visual Analogue Scale (VAS) score

  The patient will be interviewed regarding postoperative pain using Visual Analogue Scale, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable

  6 hours after surgery

Secondary Outcomes (6)

• First demand for supplementary analgesia

  Up to 24 hours postoperatively

• Postoperative VAS score

  24 hours

• Perioperative trend of Adrenaline

  At baseline, at the end of the operation, 24 hours after surgery

• Perioperative trend of Noradrenaline

  At baseline, at the end of the operation, 24 hours after surgery

• Perioperative trend of Cortisol

  At baseline, at the end of the operation, 24 hours after surgery

Study Arms (2)

Opioid Based Anaesthesia

ACTIVE COMPARATOR

This arm will receive: * 2 mcg/kg fentanyl in 10 ml volume * 0.2 mL/kg/h remifentanil infusion * 0.1 mg/kg morphine

Drug: Opioid based anesthesia

Opioid Free Anaesthesia

ACTIVE COMPARATOR

This arm will receive * 40 mg/kg magnesium sulfate in 100 ml N/S infusion * 0.4 mcg/kg dexmedetomidine, max total dose 50mcg in 50 ml N/S infusion * 0.3 mg/kg ketamine in 10 ml volume * 0.2 ml/kg of the Multimix regimen in 100 ml N/S infusion as a bolus (The Multimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine). * 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S infusion as a continuous infusion

Drug: Opioid Free Anaesthesia

Interventions

Opioid Free Anaesthesia DRUG

* 40 mg/kg magnesium sulfate in 100 ml N/S infusion * 0.4 mcg/kg dexmedetomidine, max total dose 50mcg in 50 ml N/S infusion * 0.3 mg/kg ketamine in 10 ml volume * 0.2 ml/kg of the Multimix regimen in 100 ml N/S infusion as a bolus (The Multimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine). * 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S infusion as a continuous infusion. Except for standard analgesic strategies, both groups will receive fentanyl as a rescue dose (1mcg/kg) based on a nociceptive level value \> 25 or elevation of Heart Rate and/or Blood Pressure \>20%. Placebo infusions of normal saline will be prepared to enable blinding.

Opioid Free Anaesthesia

Opioid based anesthesia DRUG

* 2 mcg/kg fentanyl in 10 ml volume * 0.2 mL/kg/h remifentanil infusion * 0.1 mg/kg morphine. Except for standard analgesic strategies, both groups will receive fentanyl as a rescue dose (1mcg/kg) based on a nociceptive level value \> 25 or elevation of Heart Rate and/or Blood Pressure \>20%. Placebo infusions of normal saline will be prepared to enable blinding.

Opioid Based Anaesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18y and \<75y
• morbid obesity confirmed diagnosis
• American Society of Anesthesiologists (ASA) II-III
• elective laparoscopic sleeve gastrectomy surgery
• signed informed consent

You may not qualify if:

• bradycardia, bundle branch block, hypotension, postural hypotension
• obstructive sleep apnoea
• history of depression
• chronic corticosteroid use or intraoperative administration of more than 8mg of prednisolone or equivalent
• refusal to participate

Sponsors & Collaborators

• G.Gennimatas General Hospital: lead
• Aristotle University Of Thessaloniki: collaborator

Study Sites (1)

G.Gennimatas General Hospital

Athens, 11527, Greece

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Agnosia

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Infusions will be prepared by independent staff not involved in the study. All preparations will be alike in the volume and appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: March 3, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

GR (1)