Clinical Trial

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

Active, Not Recruiting
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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.
Protocol Amendment History 2 changes
critical Enrollment closed, study ongoing 2026-08-04
notable Primary completion pushed: 2026-05-28 -> 2026-07-01 2026-08-04
Trial Details
NCT Number NCT05752799
Lead Sponsor G.Gennimatas General Hospital
Collaborators: Aristotle University Of Thessaloniki
Conditions Opioid Use, Unspecified, Bariatric Surgery Candidate
Enrollment 70 participants
Start Date 2023-01-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-03