Clinical trial NCT05752799: Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Official title: Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use, Unspecified
Bariatric Surgery Candidate
Keywords: morbid obesity
opioid free anaesthesia
nociception level
analgesia
bariatric surgery
Lead sponsor: G.Gennimatas General Hospital
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
First posted: 2023-03-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Opioid Free Anaesthesia has attracted the attention of clinicians since the outbreak of the opioid pandemic in the USA. It has been correlated with less intraoperative and postoperative opioid use. The Nociceptive Level Index algorithm allows for intraoperative monitoring of the nociceptive pathways and targeted pain management. Furthermore, it is known that morbidly obese patients may benefit from opioid sparing techniques.

Our aim is to investigate the effect of Opioid Free versus Opioid Based Anesthesia on postoperative pain in patients undergoing sleeve gastrectomy.

In this randomized, double blind clinical trial, patients will be allocated into two groups based on intraoperative pain management. Apart from recording postoperative pain scores, blood samples will be collected intraoperatively to evaluate the stress response among the two groups.

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

Primary outcomes:
measure: Postoperative Visual Analogue Scale (VAS) score
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: First demand for supplementary analgesia
timeFrame: Up to 24 hours postoperatively
measure: Postoperative VAS score
timeFrame: 24 hours
measure: Perioperative trend of Adrenaline
timeFrame: At baseline, at the end of the operation, 24 hours after surgery
measure: Perioperative trend of Noradrenaline
timeFrame: At baseline, at the end of the operation, 24 hours after surgery
measure: Perioperative trend of Cortisol
timeFrame: At baseline, at the end of the operation, 24 hours after surgery
measure: Perioperative trend of Dopamine
timeFrame: At baseline, at the end of the operation, 24 hours after surgery
Other outcomes:
Locations:
city: Athens
country: Greece
facility: G.Gennimatas General Hospital
Study officials:
References: