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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity; Bariatric Surgery Candidate; Opioid Use; TCI Eleveld
• Intervention / Treatment: Drug: opioid free anesthesia; Drug: Opiod Free Anesthesia with TCI ELEVELD

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11527
    • Recruiting
    • General Hospital of Athens G. Gennimatas
    • Contact: Panagiotis Chatzistavridis; Phone Number: 00306972871556; Email: p.chatzistavridis@gna-gennimatas.gr
    • Principal Investigator: Panagiotis Chatzistavridis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DOFA; 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; OFA with Desflurane; Other Names: Desflurane
Active Comparator: TIVOFA; 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; OFA without Desflurane use TCI Eleveld Model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Evaluation through the use of questionnaires QoR 40	Post operatively Day 1, Day 2 Day 15 and Day 30

Collaborators and Investigators

• Sponsor: G.Gennimatas General Hospital
• Collaborators: National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Analgesia; Morbid Obesity; Bariatric Surgery; Nociception Level; Opioid Free Anesthesia; Eleveld Model TCI
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Nutrition Disorders; Overnutrition; Body Weight; Neurobehavioral Manifestations; Overweight; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Obesity, Morbid; Agnosia; Organic Chemicals; Ethers; Hydrocarbons; Hydrocarbons, Halogenated; Hydrocarbons, Fluorinated; Methyl Ethers; Ethyl Ethers; Desflurane
• Other Study ID Numbers: 372/5.1.2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No