Clinical trial

Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA for Bariatric Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT07568938

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionOpioid Use, Bariatric Surgery Candidate, TCI Eleveld, Obesity

Full registry criteria

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

Treatments and study arms

opioid free anesthesia

Drug

OFA with Desflurane

Opiod Free Anesthesia with TCI ELEVELD

Drug

OFA without Desflurane use TCI Eleveld Model

Primary outcomes

Perioperative trend of CortisoleAt baseline, at the end of the operation, 24 hours after surgery]
Perioperative trend of AdrenalineAt baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of NoradrenalineAt baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of DopamineTime Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of ProlactineTime Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of ACTHTime Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of LactateTime Frame: At baseline, at the end of the operation, 24 hours after surgery

Study locations

1 locations were listed when this page was built. The first 40 are shown.

General Hospital of Athens G. Gennimatas🇬🇷 Athens, Greece
Panagiotis ChatzistavridisContact
Panagiotis ChatzistavridisPrincipal Investigator