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NCT Number: NCT07568938

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

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.

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Key information

Conditions

Opioid Use Agnosia Bariatric Surgery Candidate Body Weight Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms TCI Eleveld

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Athens G. Gennimatas

Athens, 11527, Greece

Location status: Recruiting

Location contact

Panagiotis Chatzistavridis

CONTACT

[email protected]

00306972871556

Panagiotis Chatzistavridis

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

opioid free anesthesia

Drug

OFA with Desflurane

Other names: Desflurane

Opiod Free Anesthesia with TCI ELEVELD

Drug

OFA without Desflurane use TCI Eleveld Model

Primary outcomes

  1. Perioperative trend of Cortisole

    Time frame: At baseline, at the end of the operation, 24 hours after surgery]

  2. Perioperative trend of Adrenaline

    Time frame: At baseline, at the end of the operation, 24 hours after surgery

  3. Perioperative trend of Noradrenaline

    Time frame: At baseline, at the end of the operation, 24 hours after surgery

  4. Perioperative trend of Dopamine

    Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery

  5. Perioperative trend of Prolactine

    Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery

  6. Perioperative trend of ACTH

    Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery

  7. Perioperative trend of Lactate

    Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery

Secondary outcomes

  1. Plasma levels of Propofol for patients receiving Propofol TCI

    Time frame: Immediately after extubation

  2. Anesthesia related adverse effects reported, including intraoperative hemodynamic instability, postoperative hypoxemia, nausea and vomit

    Time frame: 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)

  3. Long-term and short-term quality of anesthesia recovery

    Time frame: Post operatively Day 1, Day 2 Day 15 and Day 30

    Evaluation through the use of questionnaires QoR 40

Sponsors and collaborators

Lead sponsor

G.Gennimatas General Hospital

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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