NCT05752799 Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
| NCT ID | NCT05752799 |
| Status | Recruiting |
| Phase | — |
| Sponsor | G.Gennimatas General Hospital |
| Condition | Opioid Use, Unspecified |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-05-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2023-01-01 with a primary completion date of 2026-05-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05752799 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Opioid Use, Unspecified. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05752799 currently recruiting?
Yes, NCT05752799 is actively recruiting participants. Visit ClinicalTrials.gov or contact G.Gennimatas General Hospital to inquire about joining.
Where is the NCT05752799 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT05752799 clinical trial?
NCT05752799 is sponsored by G.Gennimatas General Hospital. The trial plans to enroll 70 participants.