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

G.Gennimatas General Hospital

Status: Enrolling

Conditions: Bariatric Surgery Candidate; Opioid Use, Unspecified

Treatments: Drug: Opioid Free Anaesthesia; Drug: Opioid based anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05752799

31235/1.12.2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Opioid Based Anaesthesia

Active Comparator group

Description:

This arm will receive: * 2 mcg/kg fentanyl in 10 ml volume * 0.2 mL/kg/h remifentanil infusion * 0.1 mg/kg morphine

Treatment:

Drug: Opioid based anesthesia

Opioid Free Anaesthesia

Active Comparator group

Description:

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

Treatment:

Drug: Opioid Free Anaesthesia