Desflurane and Brain Relaxation in Craniotomy

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

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.

Study Overview

• Status: Completed
• Conditions: Supratentorial Tumor
• Intervention / Treatment: Drug: Desflurane; Drug: Propofol

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Desflurane inhalational anesthesia	Drug: Desflurane; After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil.; Other Names: inhalational anesthesia
ACTIVE_COMPARATOR: Propofol total intravenous anesthesia	Drug: Propofol; After induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil; Other Names: TIVA; total intravenous anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of satisfactory brain relaxation	Assessed 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	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence time	from drug discontinuation to eye opening	from drug discontinuation to eye opening, assessed up to 1 hours
Extubation time	from drug discontinuation to tracheal extubation	from drug discontinuation to tracheal extubation, assessed up to 1 hours
Postoperative complications	incidence of hypoxemia, hypotension, hypertension, tachycardia, bradycardia, agitation, shivering.	from drug discontinuation to discharge from PACU (Postanesthesia care unit), assessed up to 3 hours
Postoperative pain and postoperative nausea and vomiting (PONV)	evaluated by Visual Analogue Score(VAS).	during the PACU stay and postoperative day 1.
Duration in PACU (Postanesthesia care unit)	time from entering PACU to exiting PACU	from entering PACU to exiting PACU, an expected average of 1 hour
Early postanesthesia cognitive recovery	evaluated by Short Orientation Memory Concentration Test (SOMCT)	at 15, 30min after tracheal extubation
Dural tension	evaluated using a 4-point scale after bone flap removal.	during surgery
Quality of anesthesia recovery	assessed by quality of recovery-15 scale (QoR-15)	at postoperative day 1
Anesthesia expenses	Total cost of anesthesia	at postoperative day 1

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 26, 2021
• Primary Completion (ACTUAL): August 30, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: December 12, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (ACTUAL): December 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Supratentorial Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Desflurane
• Other Study ID Numbers: H199510180629

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No