Desflurane and Brain Relaxation in Craniotomy

NCT04691128 | Completed

• 1 other identifier: H199510180629
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Supratentorial Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Emergence time

  from drug discontinuation to eye opening, assessed up to 1 hours

• Extubation time

  from drug discontinuation to tracheal extubation, assessed up to 1 hours

• Postoperative complications

  from drug discontinuation to discharge from PACU (Postanesthesia care unit), assessed up to 3 hours

• Postoperative pain and postoperative nausea and vomiting (PONV)

  during the PACU stay and postoperative day 1.

• Duration in PACU (Postanesthesia care unit)

  from entering PACU to exiting PACU, an expected average of 1 hour

Study Arms (2)

Desflurane inhalational anesthesia

EXPERIMENTAL

Drug: Desflurane

Propofol total intravenous anesthesia

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Desflurane DRUG

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

Also known as: inhalational anesthesia

Desflurane inhalational anesthesia

Propofol DRUG

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

Also known as: TIVA, total intravenous anesthesia

Propofol total intravenous anesthesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (1)

• Jiang Z, Wu Y, Liang F, Jian M, Liu H, Mei H, Han R. Brain relaxation using desflurane anesthesia and total intravenous anesthesia in patients undergoing craniotomy for supratentorial tumors: a randomized controlled study. BMC Anesthesiol. 2023 Jan 10;23(1):15. doi: 10.1186/s12871-023-01970-z.

  PMID: 36624384 DERIVED

MeSH Terms

Conditions

Supratentorial Neoplasms

Interventions

Desflurane; Propofol

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: December 31, 2020
• Study Start: January 26, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 31, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

CN (1)