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

ConditionsOpioid UseBariatric Surgery CandidateTCI EleveldObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorG.Gennimatas General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 )

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • opioid free anesthesia

    Drug

    OFA with Desflurane

  • Opiod Free Anesthesia with TCI ELEVELD

    Drug

    OFA without Desflurane use TCI Eleveld Model

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: DOFAActive comparator 1 intervention
Group B: TIVOFAActive comparator 1 intervention

Trial outcomes

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

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

Evaluation through the use of questionnaires QoR 40

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

G.Gennimatas General Hospital

Lead sponsor

National and Kapodistrian University of Athens

Collaborator

Source ClinicalTrials.gov
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