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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGeorgia Tsaousi

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

ASA-PS 1-3 (American Society of Anesthesiologists Physical Status classification)

Elective or semi-elective craniotomy for brain tumor resection

Signed informed consent

Disqualifiers

History of craniotomy at the same site

Morbid obesity

Delirious person before surgery

Cognitive disturbances

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    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.

Treatment groups

84 Participants
are divided into 3 treatment groups
Group A: Total intravenous anesthesia in brain tumor surgeryActive comparator 2 interventions
Group B: Sevoflurane in brain tumor surgeryExperimental treatment 1 intervention
Group C: Desflurane in brain tumor surgeryExperimental treatment 1 intervention

Trial outcomes

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
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

1

Changes in brain relaxation score

Alterations in BRS after administration of sevoflurane or desflurane or propofol as anesthetic agent

Time frame
Before dura opening
2

Changes in Μontreal Cognitive Assessment (MoCA)

Alterations in Μontreal Cognitive Assessment (MoCA) after administration of sevoflurane or desflurane or propofol as anesthetic agent.

Time frame
Preoperatively and one week following the end of surgical procedure
3

Changes in GFAP

Alterations in GFAP (ng/ml) levels after administration of sevoflurane or desflurane or propofol as anesthetic agent.

Time frame
End of surgical procedure and 24 hours postoperatively
4

Changes in UCH-L1

Alterations in UCH-L1 (ng/ml) after administration of sevoflurane or desflurane or propofol as anesthetic agent

Time frame
Baseline, end of surgical procedure and 24 hours postoperatively

Other outcomes

1

Changes in arterio-jugular oxygen difference (AjvDO2)

Alterations in arterio-jugular oxygen difference (AjvDO2 \[ml/dl\]), after 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
2

Changes in arterio-jugular carbon dioxide difference (AjvCO2)

Alterations in arterio-jugular carbon dioxide difference (AjvCO2 \[mmHg\]), 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
3

Changes in brain oxygen extraction ratio (O2Erbr)

Alterations in brain oxygen extraction ratio (O2Erbr \[%\]), 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
4

Changes in Q-40

Alterations in Q-40 after administration of sevoflurane or desflurane or propofol as anesthetic agent

Time frame
Up to hospital discharge

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgia Tsaousi

Lead sponsor

Aristotle University Of Thessaloniki

Sponsor institution