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

NCT07568938 — Not applicable, Recruiting, 70 participants, G.Gennimatas General Hospital

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

Registry	NCT07568938
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	70 (Estimated)
Sponsor	G.Gennimatas General Hospital (Other); collaborators: National and Kapodistrian University of Athens
Conditions	Opioid Use, Bariatric Surgery Candidate, TCI Eleveld, Obesity
Interventions	opioid free anesthesia, Opiod Free Anesthesia with TCI ELEVELD (Drug)
Dates	start 2024-01-10, primary completion 2027-02-28 (estimated), completion 2027-05-30 (estimated), first posted 2026-05-06, last updated 2026-05-06
Locations	1 site in Greece

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
DOFA	Active comparator	Drug: opioid free anesthesia	This arm will receive: Anesthesia Induction * 40 mg/kg Magnesium sulfate in 100 ml N/S infusion * 1 mcg/kg Dexmedetomidine, max total dose 100mcg in 50 ml N/S infusion * 0.3 mg/kg Ketamine * 0.2 ml/kg of the Mulimix regimen in 100 ml N/S infusion as a bolus (The -Mulimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine) * 2-3mg/kg Propofol (for introduction ) * 4 mg Ondansetron * 8mg Dexamethasone * 0,9-1 mg/kg Rocuronium * 40mg Parecoxib Anesthesia Maintenance * 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S * Desflurane * Fentanyl rescue dose (1mcg/kg) PostOp Analgesia * Paracetamol 1gx4 * Parecoxib 40mg 1x2 * Tramadol 100mg (For pain, the patient may take a rescue medication as needed)
TIVOFA	Active comparator	Drug: Opiod Free Anesthesia with TCI ELEVELD	This arm will receive: Anesthesia Induction * 40 mg/kg Magnesium sulfate in 100 ml N/S infusion * 1 mcg/kg Dexmedetomidine, max total dose 100mcg in 50 ml N/S infusion * 0.3 mg/kg Ketamine * 0.2 ml/kg of the Mulimix regimen in 100 ml N/S infusion as a bolus (The -Mulimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine) * Propofol Eleveld TCI model Start bolus 3mcg/ml and titrated according to EEG monitoring * 4 mg Ondansetron * 8mg Dexamethasone * 0,9-1 mg/kg Rocuronium * 40mg Parecoxib Anesthesia Maintenance * 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S * Fentanyl rescue dose (1mcg/kg) PostOp Analgesia * Paracetamol 1gx4 * Parecoxib 40mg 1x2 * Tramadol 100mg (For pain, the patient may take a rescue medication as needed)

opioid free anesthesia (Drug), also known as Desflurane: OFA with Desflurane
Opiod Free Anesthesia with TCI ELEVELD (Drug): OFA without Desflurane use TCI Eleveld Model

+Outcome measures

Primary outcomes

Perioperative trend of Cortisole [At baseline, at the end of the operation, 24 hours after surgery]]
Perioperative trend of Adrenaline [At baseline, at the end of the operation, 24 hours after surgery]
Perioperative trend of Noradrenaline [At baseline, at the end of the operation, 24 hours after surgery]
Perioperative trend of Dopamine [Time Frame: At baseline, at the end of the operation, 24 hours after surgery]
Perioperative trend of Prolactine [Time Frame: At baseline, at the end of the operation, 24 hours after surgery]
Perioperative trend of ACTH [Time Frame: At baseline, at the end of the operation, 24 hours after surgery]
Perioperative trend of Lactate [Time Frame: At baseline, at the end of the operation, 24 hours after surgery]

Secondary outcomes

Plasma levels of Propofol for patients receiving Propofol TCI [Immediately after extubation]
Anesthesia related adverse effects reported, including intraoperative hemodynamic instability, postoperative hypoxemia, nausea and vomit [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 [Post operatively Day 1, Day 2 Day 15 and Day 30]: Evaluation through the use of questionnaires QoR 40

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
General Hospital of Athens G. Gennimatas	Athens	Greece	Recruiting