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NCT05752799Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
70 (estimated)
First submitted
11 Feb 2023
Start date
1 Jan 2023
Primary completion date
1 Jul 2026
Lead sponsor
G.Gennimatas General Hospital
Diseases
Obesity
NCT number
NCT05752799

What you commit to

  • Study type: Interventional
  • Planned participants: 70
  • From 1 Jan 2023 to the primary completion date, 1 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • chronic corticosteroid use or intraoperative administration of more than 8mg of prednisolone or equivalent

Other illness

  • history of depression

Other

  • bradycardia, bundle branch block, hypotension, postural hypotension
  • obstructive sleep apnoea
  • refusal to participate

Who the study is looking for

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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
G.Gennimatas General Hospital
Coordinator of this site? Confirm its status
AthensGreeceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.