Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorG.Gennimatas General Hospital
About this trial
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
Qualifiers
Age >18y and <75y
morbid obesity confirmed diagnosis
American Society of Anesthesiologists (ASA) II-III
elective laparoscopic sleeve gastrectomy surgery
Disqualifiers
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
Trial design
Treatments tested in this trial
- Opioid Free Anaesthesia
- Opioid based anesthesia
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
G.Gennimatas General Hospital
Lead sponsor
Aristotle University Of Thessaloniki
Collaborator
Source ClinicalTrials.gov