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

NCT ID: NCT05752799

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-06-01

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.

Conditions

Opioid Use, Unspecified; Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Opioid based anesthesia

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Opioid Free Anaesthesia

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: collaborator

G.Gennimatas General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Panagiotis Chatzistavridis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

G.Gennimatas General Hospital

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Facility Contacts

Panagiotis Chatzistavridis, MD, MSc

Role: primary

p_chatzistavridis@yahoo.gr

+306972871556

Kassiani Theodoraki, Dr

Role: backup

ktheod@med.uoa.gr

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

31235/1.12.2022

Identifier Type: -

Identifier Source: org_study_id