Desflurane and Brain Relaxation in Craniotomy

Supratentorial Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691128
• Other study ID #: H199510180629
• Status: Completed
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2021
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 31, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Supratentorial Neoplasms
• Supratentorial Tumor

Intervention

Drug:
• Desflurane
After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 µg/kg/min remifentanil.
• Propofol
After induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 µg/kg/min remifentanil

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Emergence time	from drug discontinuation to eye opening	from drug discontinuation to eye opening, assessed up to 1 hours
Secondary	Extubation time	from drug discontinuation to tracheal extubation	from drug discontinuation to tracheal extubation, assessed up to 1 hours
Secondary	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
Secondary	Postoperative pain and postoperative nausea and vomiting (PONV)	evaluated by Visual Analogue Score(VAS).	during the PACU stay and postoperative day 1.
Secondary	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
Secondary	Early postanesthesia cognitive recovery	evaluated by Short Orientation Memory Concentration Test (SOMCT)	at 15, 30min after tracheal extubation
Secondary	Dural tension	evaluated using a 4-point scale after bone flap removal.	during surgery
Secondary	Quality of anesthesia recovery	assessed by quality of recovery-15 scale (QoR-15)	at postoperative day 1
Secondary	Anesthesia expenses	Total cost of anesthesia	at postoperative day 1