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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Opioid Free Anaesthesia
Drug* 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.
Opioid based anesthesia
Drug* 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Opioid Based AnaesthesiaActive comparator 1 intervention
Group B: Opioid Free AnaesthesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Visual Analogue Scale (VAS) score
The patient will be interviewed regarding postoperative pain using Visual Analogue Scale, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable
Time frame
6 hours after surgerySecondary outcomes
1
First demand for supplementary analgesia
The time to the first demand for supplementary analgesia will be recorded for every patient enrolled.
Time frame
Up to 24 hours postoperatively2
Postoperative VAS score
The patient will be interviewed regarding postoperative pain using Visual Analogue Scale, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable
Time frame
24 hours3
Perioperative trend of Adrenaline
Blood will be collected to measure the plasma adrenaline levels
Time frame
At baseline, at the end of the operation, 24 hours after surgery4
Perioperative trend of Noradrenaline
Blood will be collected to measure the plasma Noradrenaline levels
Time frame
At baseline, at the end of the operation, 24 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
G.Gennimatas General Hospital
Lead sponsor
Aristotle University Of Thessaloniki
Collaborator
Source ClinicalTrials.gov