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Desflurane and Brain Relaxation in Craniotomy

Comparison of Desflurane and Propofol for Brain Relaxation in Patients Undergoing Supratentorial Craniotomy:a Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04691128
Enrollment
111
Registered
2020-12-31
Start date
2021-01-26
Completion date
2021-08-31
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supratentorial Tumor

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.

Interventions

DRUGDesflurane

After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil.

DRUGPropofol

After induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of satisfactory brain relaxationduring surgeryAssessed by the neurosurgeon using a 4-point scale (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain) at the opening of the dura mater, score 1 and 2 represent satisfactory brain relaxation

Secondary

MeasureTime frameDescription
Dural tensionduring surgeryevaluated using a 4-point scale after bone flap removal.
Quality of anesthesia recoveryat postoperative day 1assessed by quality of recovery-15 scale (QoR-15)
Emergence timefrom drug discontinuation to eye opening, assessed up to 1 hoursfrom drug discontinuation to eye opening
Extubation timefrom drug discontinuation to tracheal extubation, assessed up to 1 hoursfrom drug discontinuation to tracheal extubation
Early postanesthesia cognitive recoveryat 15, 30min after tracheal extubationevaluated by Short Orientation Memory Concentration Test (SOMCT)
Postoperative pain and postoperative nausea and vomiting (PONV)during the PACU stay and postoperative day 1.evaluated by Visual Analogue Score(VAS).
Duration in PACU (Postanesthesia care unit)from entering PACU to exiting PACU, an expected average of 1 hourtime from entering PACU to exiting PACU
Anesthesia expensesat postoperative day 1Total cost of anesthesia
Postoperative complicationsfrom drug discontinuation to discharge from PACU (Postanesthesia care unit), assessed up to 3 hoursincidence of hypoxemia, hypotension, hypertension, tachycardia, bradycardia, agitation, shivering.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026