A Phase 4 interventional study of Sevoflurane and Desflurane in Brain Edema Caused by Drugs and Cerebral Oxygenation, sponsored by Georgia Tsaousi. Recruiting at 2 sites in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Georgia Tsaousi · Phase 4, Interventional, and Prevention
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.
Each participant will receive standard monitoring (ECG, SpO2, SBP, BIS, urine output, temperature). More detailed hemodynamic monitoring will be obtained by the Edwards Lifesciences ClearSight system (CO, CI, SV, SVI, SVV, SVR, SVRI), while the analgesic efficacy of remifentanil will be assessed by Nociception index (NOL) monitoring.
TCI Remifentanil and propofol 2 mg/kg bolus dose will be the agents of choice for induction in anesthesia and cisatracurium will be used for neuromuscular blockade for intubation, while maintenance of anesthesia will be either volatile-based (sevoflurane or desflurane in low flow anesthesia approach) or propofol-based (TCI mode).
Protective mechanical ventilation will be chosen (7ml/kg IBW) with a respiratory rate to obtain a PaCO2 of 35-40 mmHg. PEEP will be changed for the best PaO2/FiO2 ratio and FiO2 of choice will be 0.5.
The radial artery catheterization will be applied for direct blood pressure measurement and arterial blood gas sampling (pH, PaO2, PaCO2, HCO3, BE, osmolality, lactic acid, Hb, glucose, Na and K will be measured).
The jugular bulb ipsilateral to the craniotomy site will be catheterized for receiving blood samples for blood gas analysis. The following oxygenation and metabolic parameters / derivates will be registered or calculated: SjvO2, pH, PjvO2, PjvCO2, HCO3, BE, Osmolality, Lactic acid jv, Hb, Glucose, Na, K, AjvDO2, AjvCO2, O2ERbr, eRQbr, AjvDL, and LOI.
Phases
Phase T120 will be obtained with MAC= 1.2 for both volatile agents.
Blood samples for measuring S-100b, UCH-L1, GFAP will be obtained at phases T0, 6 hours, and 24 hours after administration of either sevoflurane, desflurane, or propofol Intraoperative consumption of volatile agents (sevoflurane or desflurane), propofol, and remifentanil will also be recorded.
Upon the opening of the dura matter the level of brain relaxation will be rated on a four-point scale (1. Completely relaxed, 2 sufficiently relaxed, 3 firm brain, 4 bulging brain) both by anesthesiologists and surgeons.
Awakening profile and emergence from anesthesia will be evaluated by the time needed for eye opening, response to verbal command, and extubation after discontinuation of administration of the anesthesia agent.
The Aldrete scoring system will be used for postanesthetic recovery assessment 30, 120 and 180 minutes during PACU stay. The Aldrete Scoring system consists of 5 clinically relevant parameters: muscle activity, respiration, circulation, consciousness and oxygen saturation.
Apfel score will be used for postoperative nausea and vomiting prediction. Any medication administered on PACU will be noted.
Recovery will be evaluated using two different scales. The Glasgow Outcome Scale- Extended (GOSE) assessment of global disability and recovery after traumatic brain injury will be applied both after PACU and hospital discharge. The quality of recovery- 40 is a 40-item questionnaire (QoR- 40) and will take place 24 hours postoperative and on discharge.
Neurocognitive testing will be performed at pre-anesthetic assessment, and 1 week after surgery completion using the Μontreal Cognitive Assessment (MoCA) scale.
102 studies on the registry are indexed under Brain Edema; 25 are open to participants now.
This study's planned enrollment of 84 is above the median of 60 across 62 interventional studies indexed under Brain Edema.
Browse Brain Edema studies →Georgia Tsaousi is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Propofol will be administered at concentrations maintaining BIS 40-60 up to surgery completion.
Drug: Sevoflurane · Drug: Desflurane
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 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
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 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
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
Changes in brain relaxation score
Alterations in BRS after administration of sevoflurane or desflurane or propofol as anesthetic agent
Time frame: Before dura opening
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
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
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
Changes in S-100b protein
Alterations in S-100b (μg/L) after administration of sevoflurane or desflurane or propofol as anesthetic agent.
Time frame: Baseline, end of surgical procedure and 24 hours postoperatively
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
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
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
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
Plan to share: No
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Started May 2025 (actual). Primary completion is estimated for Sep 2026, 16 months after the start.
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Studies of the drugs tested here: Sevoflurane · Desflurane
Georgia Tsaousi