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Recruiting NCT07568938

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

No phase Interventional Opioid Use Bariatric Surgery Candidate TCI Eleveld Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: opioid free anesthesia, Opiod Free Anesthesia with TCI ELEVELD.
Who it may be relevant to
Registry conditions: Opioid Use, Bariatric Surgery Candidate, TCI Eleveld, Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug opioid free anesthesia
    OFA with Desflurane
  • Drug Opiod Free Anesthesia with TCI ELEVELD
    OFA without Desflurane use TCI Eleveld Model

Primary outcome measures

  • Perioperative trend of Cortisole [Time frame: At baseline, at the end of the operation, 24 hours after surgery]]
  • Perioperative trend of Adrenaline [Time frame: At baseline, at the end of the operation, 24 hours after surgery]
  • Perioperative trend of Noradrenaline [Time frame: At baseline, at the end of the operation, 24 hours after surgery]
  • Perioperative trend of Dopamine [Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery]
  • Perioperative trend of Prolactine [Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery]
  • Perioperative trend of ACTH [Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery]
  • Perioperative trend of Lactate [Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery]
Secondary outcome measures (3)
  • Plasma levels of Propofol for patients receiving Propofol TCI [Time frame: Immediately after extubation]
  • 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)]
  • Long-term and short-term quality of anesthesia recovery [Time frame: Post operatively Day 1, Day 2 Day 15 and Day 30]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Greece · 1 center
  • General Hospital of Athens G. Gennimatas — Athens

Identifiers

NCT: NCT07568938 · 372/5.1.2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗