RecruitingNot Applicable

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

Greece70 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Postoperative Visual Analogue Scale (VAS) score

Timeframe: 6 hours after surgery

Trial details

NCT IDNCT05752799

SponsorG.Gennimatas General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-28

View on ClinicalTrials.gov More Opioid Use, Unspecified trials