Clinical trial NCT04691128: Desflurane and Brain Relaxation in Craniotomy
Official title: Comparison of Desflurane and Propofol for Brain Relaxation in Patients Undergoing Supratentorial Craniotomy：a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supratentorial Tumor
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Optional brain relaxation improves the surgeon's operating conditions and is likely to minimize the degree of retraction injury ,with the potential for providing patients with a better outcome. The choice of anesthetic drugs can affect intraoperative brain relaxation. Propofol suppresses brain metabolism, reduces cerebral blood flow, and provides satisfactory brain relaxation. Desflurane is often criticized in neurosurgery due to its cerebral vasodilation and potential to increase intracranial pressure, however, it has been found to have a little clinical significance. This study intends to compare the effects of desflurane with propofol on brain relaxation in patients with supratentorial tumors under mild hyperventilation, and to provide new clinical evidence for the use of desflurane in neurosurgical anesthesia.

Detailed description: To compare the effect of desflurane versus propofol combined with remifentanil anesthesia on brain relaxation in patients undergoing supratentorial tumor surgery with mild hyperventilation, and compare the emergence time and common complications during recovery.

Eligibility criteria: Inclusion Criteria:

* 18-60 years
* Scheduled for elective craniotomy for supratentorial cerebral tumors
* ASA status I-III
* Glasgow score of 15
* No clinical signs of intracranial hypertension
* Preoperative brain imaging (CT or MRI) with midline shift less than 5mm
* Informed consent signed by patients

Exclusion Criteria:

* Scheduled intraoperative motor evoked potential monitoring
* Patients with cerebral vascular diseases
* Uncontrolled cardiopulmonary disease
* Schedule to retain tracheal intubation after surgery
* Unable to comprehend and cooperate with the examination
* BMI \> 30 Kg/m-2
* Emergency surgery
* History of related anesthetic allergy

Primary outcomes:
measure: Proportion of satisfactory brain relaxation
timeFrame: during surgery
Secondary outcomes:
measure: Emergence time
timeFrame: from drug discontinuation to eye opening, assessed up to 1 hours
measure: Extubation time
timeFrame: from drug discontinuation to tracheal extubation, assessed up to 1 hours
measure: Postoperative complications
timeFrame: from drug discontinuation to discharge from PACU (Postanesthesia care unit), assessed up to 3 hours
measure: Postoperative pain and postoperative nausea and vomiting (PONV)
timeFrame: during the PACU stay and postoperative day 1.
measure: Duration in PACU (Postanesthesia care unit)
timeFrame: from entering PACU to exiting PACU, an expected average of 1 hour
measure: Early postanesthesia cognitive recovery
timeFrame: at 15, 30min after tracheal extubation
measure: Dural tension
timeFrame: during surgery
measure: Quality of anesthesia recovery
timeFrame: at postoperative day 1
measure: Anesthesia expenses
timeFrame: at postoperative day 1
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References: