NCT06779890 Effect of Volatile- Based Versus Total Intravenous Anesthesia on Brain Homeostasis and Neurocognitive Outcome
| NCT ID | NCT06779890 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Georgia Tsaousi |
| Condition | Brain Edema Caused by Drugs |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 84 participants in total. It began in 2025-05-12 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The brain is a metabolic active organ with constant energy demands. Brain oxygen supply is secured via cerebral circulation. Brain tumor surgery is commonly associated with the tumor's underlying pathophysiology including brain swelling or edema. During craniotomy for brain tumor resection maintenance of cerebral hemodynamic stability is of paramount importance. Neuroinflammation is also a normal response to trauma, such as in the case of brain tumor surgery. The role of neuroinflammation in postoperative brain function is well documented and the aim is to limit it through an appropriate anesthetic approach. Anesthetic agents used during surgery affect brain homeostasis. The anesthetic agent of choice for neurosurgery should deliver smooth and hemodynamically stable anesthesia, good operating conditions, and allow early neurological assessment. Also, the ideal anesthetic agent should preserve cerebral perfusion and neuroprotection. The two most common categories of anesthetic agents used nowadays for elective craniotomy are intravenous and inhalational agents. Propofol is the intravenous anesthetic agent of choice. The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gamma-aminobutyric acid (GABA). Propofol causes a decrease in cerebral metabolic rate (CMR), intracranial pressure (ICP), cerebral perfusion pressure (CPP), and cerebral blood flow (CBF). It also is known for its antiemetic properties. Volatile agents commonly used in neuroanesthesia clinical practice are sevoflurane and desflurane. Both of these agents decrease CMR while maintaining stable CPP. CBF alteration is dose-dependent. Desflurane evokes a greater cerebral vasodilation effect than sevoflurane. Sevoflurane is a well-known neuroprotective anesthetic agent traditionally used in neurosurgery. Both desflurane and sevoflurane are associated with early emergence. Thus, this study aimed to explore the effect of volatile-based versus total intravenous anesthesia on cerebral homeostasis and neurocognitive function in patients undergoing elective craniotomy for brain tumor excision aiming to provide a basis for clinical rational drug use in patients undergoing craniotomy resection of supratentorial lesions.
Eligibility 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
Contact & Investigator
Georgia Tsaousi, Professor
PRINCIPAL INVESTIGATOR
Aristotle University Of Thessaloniki
Frequently Asked Questions
Who can join the NCT06779890 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Brain Edema Caused by Drugs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06779890 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06779890 currently recruiting?
Yes, NCT06779890 is actively recruiting participants. Contact the research team at tsaousig@otenet.gr for enrollment information.
Where is the NCT06779890 trial being conducted?
This trial is being conducted at Thessaloniki, Greece, Thessaloniki, Greece.
Who is sponsoring the NCT06779890 clinical trial?
NCT06779890 is sponsored by Georgia Tsaousi. The principal investigator is Georgia Tsaousi, Professor at Aristotle University Of Thessaloniki. The trial plans to enroll 84 participants.