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

Sponsor
G.Gennimatas General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05752799
Collaborator
Aristotle University Of Thessaloniki (Other)
70
1
2
13
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Opioid Free Anaesthesia
  • Drug: Opioid based anesthesia
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Infusions will be prepared by independent staff not involved in the study. All preparations will be alike in the volume and appearance.
Primary Purpose:
Treatment
Official Title:
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Opioid based anesthesia
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.

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

Drug: Opioid Free Anaesthesia
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.

Outcome Measures

Primary Outcome Measures

  1. Postoperative Visual Analogue Scale (VAS) score [6 hours after surgery]

    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

Secondary Outcome Measures

  1. First demand for supplementary analgesia [Up to 24 hours postoperatively]

    The time to the first demand for supplementary analgesia will be recorded for every patient enrolled.

  2. Postoperative VAS score [24 hours]

    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

  3. Perioperative trend of Adrenaline [At baseline, at the end of the operation, 24 hours after surgery]

    Blood will be collected to measure the plasma adrenaline levels

  4. Perioperative trend of Noradrenaline [At baseline, at the end of the operation, 24 hours after surgery]

    Blood will be collected to measure the plasma Noradrenaline levels

  5. Perioperative trend of Cortisol [At baseline, at the end of the operation, 24 hours after surgery]

    Blood will be collected to measure the plasma Cortisol levels

  6. Perioperative trend of Dopamine [At baseline, at the end of the operation, 24 hours after surgery]

    Blood will be collected to measure the plasma Dopamine levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 G.Gennimatas General Hospital Athens Greece 11527

Sponsors and Collaborators

  • G.Gennimatas General Hospital
  • Aristotle University Of Thessaloniki

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Panagiotis Chatzistavridis, Principal Investigator, G.Gennimatas General Hospital
ClinicalTrials.gov Identifier:
NCT05752799
Other Study ID Numbers:
  • 31235/1.12.2022
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Panagiotis Chatzistavridis, Principal Investigator, G.Gennimatas General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2023