Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05752799

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

Led by G.Gennimatas General Hospital · Updated on 2026-04-28

70

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

G

G.Gennimatas General Hospital

Lead Sponsor

A

Aristotle University Of Thessaloniki

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >18 years and <75 years
  • Confirmed diagnosis of morbid obesity
  • American Society of Anesthesiologists (ASA) physical status class II or III
  • Scheduled for elective laparoscopic sleeve gastrectomy surgery
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • History of bradycardia, bundle branch block, hypotension, or postural hypotension
  • Presence of obstructive sleep apnea
  • History of depression
  • Chronic use of corticosteroids or intraoperative administration of more than 8 mg of prednisolone or equivalent
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

G.Gennimatas General Hospital

Athens, Greece, 11527

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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