Volatile gases versus IV propofol to protect the brain during craniotomy
Effect of Volatile-based Versus Total Intravenous Anesthesia on Cerebral Homeostasis and Neucognitive Function in Patients Undergoing Elective Craniotomy for Brain Tumor Excision.
This trial tests whether using volatile anesthetics (sevoflurane or desflurane) or a propofol-based total intravenous anesthesia during craniotomy for brain tumor affects brain oxygen balance, swelling, and early thinking after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 2 sites (Thessaloniki and 1 other locations) |
| Trial ID | NCT06779890 on ClinicalTrials.gov |
What this trial studies
Adults having elective or semi-elective craniotomy for brain tumor resection receive standard induction with remifentanil and propofol and neuromuscular blockade, then are maintained with either low-flow volatile anesthesia (sevoflurane or desflurane) or propofol via target-controlled infusion. Continuous hemodynamic monitoring (ClearSight), BIS, NOL analgesia monitoring, arterial line sampling and ipsilateral jugular bulb catheterization are used to measure cerebral oxygenation, metabolic markers and derived parameters at predefined time points. Protective ventilation and standardized arterial and jugular blood gas panels are applied to control physiologic variables. The study excludes patients with prior craniotomy at the same site, morbid obesity, preoperative delirium or cognitive disturbance, significant heart conduction problems, pregnancy, certain antihypertensive regimens, or liver/renal failure.
Who should consider this trial
Good fit: Adults with ASA physical status 1–3 scheduled for elective or semi-elective craniotomy for brain tumor resection who can give informed consent are the intended participants.
Not a fit: Patients with prior craniotomy at the same site, morbid obesity, preexisting delirium or cognitive impairment, significant heart block or very low heart rate, pregnancy, use of certain alpha-2 agonists, or severe liver or kidney failure are excluded and unlikely to benefit from the trial findings.
Why it matters
Potential benefit: If successful, the results could help clinicians choose the anesthesia method that better preserves brain oxygenation and reduces postoperative swelling and cognitive problems after tumor surgery.
How similar studies have performed: Prior work shows anesthetic choice can change cerebral physiology, but conclusive evidence that one approach improves postoperative cognitive outcomes after brain tumor surgery is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA-PS 1-3 (American Society of Anesthesiologists Physical Status classification) * Elective or semi-elective craniotomy for brain tumor resection * Signed informed consent Exclusion Criteria: * History of craniotomy at the same site * Morbid obesity * Delirious person before surgery * Cognitive disturbances * Preoperative heart rate (HR) \<45 beats/min or second or third degree AV block * Treatment with a-methyldopa, clonidine or other a2-adrenergic agonist * Pregnancy * Liver or renal failure
Where this trial is running
Thessaloniki and 1 other locations
- AHEPA University Hospital — Thessaloniki, Greece (Recruiting)
- Aristotle University of Thessaloniki — Thessaloniki, Greece (Recruiting)
Study contacts
- Principal investigator: Georgia Tsaousi, Professor — Aristotle University Of Thessaloniki
- Study coordinator: Georgia Tsaousi, Professor
- Email: tsaousig@otenet.gr
- Phone: +302310994855
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.