Stress response with desflurane versus opioid-free TIVA during weight-loss surgery
Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA TCI ELEVELD Model for Bariatric Surgery
NA · G.Gennimatas General Hospital · NCT07568938
This study will test whether adding the inhaled anesthetic desflurane to opioid-free anesthesia changes the body's perioperative stress response in people having bariatric (weight-loss) surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | G.Gennimatas General Hospital (other) |
| Locations | 1 site (Athens) |
| Trial ID | NCT07568938 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for laparoscopic sleeve gastrectomy or gastric bypass will be assigned to receive opioid-free anesthesia either with desflurane (volatile) or without it using target-controlled infusions (TCI Eleveld) for intravenous agents. Blood samples will be drawn perioperatively to measure cortisol, ACTH, dopamine, prolactin, adrenaline, noradrenaline, and lactate as biomarkers of stress. Nociception and analgesia management will follow the assigned anesthesia approach and intraoperative data will be compared between groups. Exclusion criteria include significant cardiac conduction abnormalities, high obstructive sleep apnea risk, prior long-term corticosteroid use, or depression, which may affect stress responses or study safety.
Who should consider this trial
Good fit: Adults with morbid obesity who are ASA II–III and approved for laparoscopic sleeve gastrectomy or gastric bypass who can give informed consent are the intended participants.
Not a fit: Patients with major contraindications listed in the protocol (for example significant bradycardia or AV block, QTcF >470 ms, high STOP-BANG score, long-term corticosteroid exposure, or active depression) or those undergoing other types of surgery are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the findings could identify an anesthetic approach that reduces perioperative stress and potentially improves recovery after bariatric surgery.
How similar studies have performed: Previous small studies of opioid-free anesthesia and comparisons of volatile versus intravenous techniques have produced mixed or limited evidence on stress biomarkers, so this specific comparison remains partially novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Athens
- General Hospital of Athens G. Gennimatas — Athens, Greece (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use, Bariatric Surgery Candidate, TCI Eleveld, Obesity, Morbid Obesity, Opioid Free Anesthesia, Nociception Level, Analgesia