Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
31235/1.12.2022
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2025-02-28
Trial end
2025-06-01
Status
Recruiting
Treatment
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.
Arms:
Opioid Free Anaesthesia
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.
Arms:
Opioid Based Anaesthesia
Size
70
Primary endpoint
Postoperative Visual Analogue Scale (VAS) score
6 hours after surgery
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Infusions will be prepared by independent staff not involved in the study. All preparations will be alike in the volume and appearance.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2024-03-19

1 organization

2 products

3 indications

Organization
G.Gennimatas General Hospital
Product
Opioid Free Anaesthesia
Indication
Opioid Use
Indication
Unspecified
Indication
Bariatric Surgery Candidate
Product
Opioid based anesthesia