Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIV… (NCT07568938) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA for Bariatric Surgery
Greece70 participantsStarted 2024-01-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perioperative trend of Cortisole
Timeframe: At baseline, at the end of the operation, 24 hours after surgery]
2
Perioperative trend of Adrenaline
Timeframe: At baseline, at the end of the operation, 24 hours after surgery
3
Perioperative trend of Noradrenaline
Timeframe: At baseline, at the end of the operation, 24 hours after surgery
4
Perioperative trend of Dopamine
Timeframe: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
5
Perioperative trend of Prolactine
Timeframe: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
6
Perioperative trend of ACTH
Timeframe: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
7
Perioperative trend of Lactate
Timeframe: Time Frame: At baseline, at the end of the operation, 24 hours after surgery