RecruitingN/AOther

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

Sponsored by G.Gennimatas General Hospital

NCT ID
NCT05752799
Target Enrollment
70 participants
Start Date
2023-01-01
Est. Completion
2025-06-01

About This Study

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 Studied

Opioid Use, UnspecifiedBariatric Surgery Candidate

Interventions

  • Opioid Free Anaesthesia
  • Opioid based anesthesia

Eligibility

Age:18 Years - 75 Years
Healthy Volunteers:No
View full 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

Study Locations (1)

G.Gennimatas General Hospital
Athens, Greece

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

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