Effect of Volatile- Based Versus Total Intravenous Anesthesia on Brain Homeostasis and Neurocognitive Outcome

NCT06779890 | Recruiting Phase 4

• 1 other identifier: TIVAVolaBrain
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Brain Edema Caused by Drugs; Cerebral Oxygenation

Keywords

sevoflurane; desflurane; total intravenous anesthesia; brain edema; brain oxygenation; neurocognitive outcome

Outcome Measures

Primary Outcomes (1)

• Changes in jugular venous oxygen saturation

  Alterations in jugular venous oxygen saturation (%), after administration of sevoflurane or desflurane or propofol as anesthetic agent

  Time Frame: At baseline (start of propofol or sevoflurane or desflurane), 30 minutes, 60 minutes, 120 minutes, 180 minutes and at the end of surgical procedure

Secondary Outcomes (5)

• Changes in brain relaxation score

  Before dura opening

• Changes in Μontreal Cognitive Assessment (MoCA)

  Preoperatively and one week following the end of surgical procedure

• Changes in GFAP

  End of surgical procedure and 24 hours postoperatively

• Changes in UCH-L1

  Baseline, end of surgical procedure and 24 hours postoperatively

• Changes in S-100b protein

  Baseline, end of surgical procedure and 24 hours postoperatively

Other Outcomes (4)

• Changes in arterio-jugular oxygen difference (AjvDO2)

  At baseline (start of propofol or sevoflurane or desflurane), 30 minutes, 60 minutes, 120 minutes, 180 minutes and at the end of surgical procedure

• Changes in arterio-jugular carbon dioxide difference (AjvCO2)

  At baseline (start of propofol or sevoflurane or desflurane), 30 minutes, 60 minutes, 120 minutes, 180 minutes and at the end of surgical procedure

• Changes in brain oxygen extraction ratio (O2Erbr)

  At baseline (start of propofol or sevoflurane or desflurane), 30 minutes, 60 minutes, 120 minutes, 180 minutes and at the end of surgical procedure

Study Arms (3)

Total intravenous anesthesia in brain tumor surgery

ACTIVE COMPARATOR

Propofol will be administered at concentrations maintaining BIS 40-60 up to surgery completion.

Drug: Sevoflurane; Drug: Desflurane

Sevoflurane in brain tumor surgery

EXPERIMENTAL

Sevoflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion.

Drug: Desflurane

Desflurane in brain tumor surgery

EXPERIMENTAL

Desflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion.

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

Sevoflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion.

Desflurane in brain tumor surgery; Total intravenous anesthesia in brain tumor surgery

Desflurane DRUG

Desflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion.

Also known as: Suprane

Sevoflurane in brain tumor surgery; Total intravenous anesthesia in brain tumor surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA-PS 1-3 (American Society of Anesthesiologists Physical Status classification)
• Elective or semi-elective craniotomy for brain tumor resection
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia Tsaousi: lead

Study Sites (2)

AHEPA University Hospital

Thessaloniki, 54645, Greece

RECRUITING

Aristotle University of Thessaloniki

Thessaloniki, 56224, Greece

RECRUITING

MeSH Terms

Conditions

Brain Edema

Interventions

Sevoflurane; Desflurane

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Georgia Tsaousi, Professor

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgia Tsaousi, Professor

CONTACT

+302310994855; tsaousig@otenet.gr

Eleni Chatsiou, MD

CONTACT

+306979314710; eleni.chatsiou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 17, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)