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

NCT07568938 | Recruiting

• 1 other identifier: 372/5.1.2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use; Bariatric Surgery Candidate; TCI Eleveld; Obesity

Keywords

Morbid Obesity; Opioid Free Anesthesia; Nociception Level; Analgesia; Bariatric Surgery; Eleveld Model TCI

Outcome Measures

Primary Outcomes (7)

• 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 (3)

• 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

Study Arms (2)

DOFA

ACTIVE COMPARATOR

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)

Drug: opioid free anesthesia

TIVOFA

ACTIVE COMPARATOR

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)

Drug: Opiod Free Anesthesia with TCI ELEVELD

Interventions

opioid free anesthesia DRUG

OFA with Desflurane

Also known as: Desflurane

DOFA

Opiod Free Anesthesia with TCI ELEVELD DRUG

OFA without Desflurane use TCI Eleveld Model

TIVOFA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• G.Gennimatas General Hospital: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

General Hospital of Athens G. Gennimatas

Athens, 11527, Greece

RECRUITING

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Agnosia

Interventions

Desflurane

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSC, PHD(c) Resident of Anaesthesiology

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 6, 2026
• Study Start: January 10, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

GR (1)