Opioid Use, Unspecified, Bariatric Surgery Candidate
Conditions
Keywords
morbid obesity, opioid free anaesthesia, nociception level, analgesia, bariatric surgery
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.
Interventions
* 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.
* 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.
Sponsors
Aristotle University Of Thessaloniki
G.Gennimatas General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
Countries
Greece
Outcome results
None listed