Bariatric Surgery Candidate, Obesity, Opioid Use, TCI Eleveld
Conditions
Keywords
Morbid Obesity, Opioid Free Anesthesia, Nociception Level, Analgesia, Bariatric Surgery, Eleveld Model TCI
Brief summary
The goal of this clinical trial is to compare the effects of Opioid Free Anesthesia (OFA) with and without volatile anesthetics (in this case desflurane) in patients undergoing bariatric surgery. The main question it aims to answer : -Will there be a difference in the perioperative stress between patients receiving OFA with and without desflurane? Participants will undergoing sleeve gastrectomy or gastric by pass, will be administered OFA with and without desflurane and blood tests (cortisole, ACTH,dopamine, PRL, adrenaline, noradrenaline, lactate) will be collected perioperatively to compare stress in the two groups.
Interventions
DRUGopioid free anesthesia
OFA with Desflurane
DRUGOpiod Free Anesthesia with TCI ELEVELD
OFA without Desflurane use TCI Eleveld Model
Sponsors
G.Gennimatas General Hospital
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent * ASA II-III * Morbid obesity confirmed diagnosis and approval for surgical treatment * Laparoscopic sleeve gastrectomy (LSG) or Gastric By pass (R-Y By pass /SASI/SADI AND one anastomosis by pass ) * Preop respiratrory assessment conducted * Adequate organ and bone marrow function
Exclusion criteria
* Patients declining or withdrawing consent * Patients unsuitabe with regards to compliance to treatment, according to the researcher's assessment * Bradycardia, AV block, , postural hypotension * QTcF\>470msec * Known allergy or hypersensitiity to any of the medications administered * Stop-BANG score \>6 * Intraoperative administration of more than 8mg of prednisolone or equivalent * Patients who have received corticosteroids for durations \>3 weeks at any point in their lifetime * Participation in other clinical trial for experimental product administered post operatively * Diagnosis of depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative trend of Cortisole | At baseline, at the end of the operation, 24 hours after surgery] |
| Perioperative trend of Adrenaline | At baseline, at the end of the operation, 24 hours after surgery |
| Perioperative trend of Noradrenaline | At baseline, at the end of the operation, 24 hours after surgery |
| Perioperative trend of Dopamine | Time Frame: At baseline, at the end of the operation, 24 hours after surgery |
| Perioperative trend of Prolactine | Time Frame: At baseline, at the end of the operation, 24 hours after surgery |
| Perioperative trend of ACTH | Time Frame: At baseline, at the end of the operation, 24 hours after surgery |
| Perioperative trend of Lactate | Time Frame: At baseline, at the end of the operation, 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma levels of Propofol for patients receiving Propofol TCI | Immediately after extubation | — |
| Anesthesia related adverse effects reported, including intraoperative hemodynamic instability, postoperative hypoxemia, nausea and vomit | Baseline (preoperative), immediately postoperatively, and 24 hours postoperatively During surgery and through 24 hours after surgery, Immediately after extubation Up to 24 hours postoperatively, DAY 2 DAY 15 and DAY 30 postoperative (QoR-40) | — |
| Long-term and short-term quality of anesthesia recovery | Post operatively Day 1, Day 2 Day 15 and Day 30 | Evaluation through the use of questionnaires QoR 40 |
Countries
Greece
Outcome results
None listed