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

NCT05752799 · G.Gennimatas General Hospital

Closed to entry
Status
Not accepting participants
Not applicable
Phase
70
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Postoperative Visual Analogue Scale (VAS) score

    Measured over 6 hours after surgery

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 75 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Age \>18y and \<75y * morbid obesity confirmed diagnosis * American Society of Anesthesiologists (ASA) II-III * elective laparoscopic sleeve gastrectomy surgery * signed informed consent Exclusion Criteria: * 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

Where

1 study site

FacilityCityRegionCountry
G.Gennimatas General HospitalAthens—Greece

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05752799 on ClinicalTrials.gov →

Last updated in the registry 2026-08-03. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance