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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age \>18y and \<75y

• morbid obesity confirmed diagnosis

• American Society of Anesthesiologists (ASA) II-III

• elective laparoscopic sleeve gastrectomy surgery

• signed informed consent

Locations
Other Locations
Greece
G.Gennimatas General Hospital
RECRUITING
Athens
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 70
Treatments
Active_comparator: Opioid Based Anaesthesia
This arm will receive:~* 2 mcg/kg fentanyl in 10 ml volume~* 0.2 mL/kg/h remifentanil infusion~* 0.1 mg/kg morphine
Active_comparator: Opioid Free Anaesthesia
This arm will receive~* 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
Related Therapeutic Areas
Sponsors
Collaborators: Aristotle University Of Thessaloniki
Leads: G.Gennimatas General Hospital

This content was sourced from clinicaltrials.gov