Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
G.Gennimatas General Hospital
Athens, Greece, 11527
Actively Recruiting
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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