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

NCT05752799 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • Opioid Use, Unspecified
  • Bariatric Surgery Candidate

Interventions

DRUG

Opioid Free Anaesthesia

* 40 mg/kg magnesium sulfate in 100 ml N/S infusion * 0.4 mcg/kg dexmedetomidine, max total dose 50mcg in 50 ml N/S infusion * 0.3 mg/kg ketamine in 10 ml volume * 0.2 ml/kg of the Multimix regimen in 100 ml N/S infusion as a bolus (The Multimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine). * 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S infusion as a continuous infusion. Except for standard analgesic strategies, both groups will receive fentanyl as a rescue dose (1mcg/kg) based on a nociceptive level value \> 25 or elevation of Heart Rate and/or Blood Pressure \>20%. Placebo infusions of normal saline will be prepared to enable blinding.

DRUG

Opioid based anesthesia

* 2 mcg/kg fentanyl in 10 ml volume * 0.2 mL/kg/h remifentanil infusion * 0.1 mg/kg morphine. Except for standard analgesic strategies, both groups will receive fentanyl as a rescue dose (1mcg/kg) based on a nociceptive level value \> 25 or elevation of Heart Rate and/or Blood Pressure \>20%. Placebo infusions of normal saline will be prepared to enable blinding.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    collaborator OTHER

  • G.Gennimatas General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2026-05-28
Completion
2027-06-01

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05752799 on ClinicalTrials.gov