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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752799
• Other study ID #: 31235/1.12.2022
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: G.Gennimatas General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Opioid Use, Unspecified

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	G.Gennimatas General Hospital	Athens

Sponsors (2)

Lead Sponsor	Collaborator
G.Gennimatas General Hospital	Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 hours after surgery
Secondary	First demand for supplementary analgesia	The time to the first demand for supplementary analgesia will be recorded for every patient enrolled.	Up to 24 hours postoperatively
Secondary	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	24 hours
Secondary	Perioperative trend of Adrenaline	Blood will be collected to measure the plasma adrenaline levels	At baseline, at the end of the operation, 24 hours after surgery
Secondary	Perioperative trend of Noradrenaline	Blood will be collected to measure the plasma Noradrenaline levels	At baseline, at the end of the operation, 24 hours after surgery
Secondary	Perioperative trend of Cortisol	Blood will be collected to measure the plasma Cortisol levels	At baseline, at the end of the operation, 24 hours after surgery
Secondary	Perioperative trend of Dopamine	Blood will be collected to measure the plasma Dopamine levels	At baseline, at the end of the operation, 24 hours after surgery