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Desflurane and Brain Relaxation in Craniotomy

Primary Purpose

Supratentorial Tumor

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Desflurane
Propofol
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Supratentorial Tumor

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Desflurane inhalational anesthesia

Propofol total intravenous anesthesia

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Emergence time
from drug discontinuation to eye opening
Extubation time
from drug discontinuation to tracheal extubation
Postoperative complications
incidence of hypoxemia, hypotension, hypertension, tachycardia, bradycardia, agitation, shivering.
Postoperative pain and postoperative nausea and vomiting (PONV)
evaluated by Visual Analogue Score(VAS).
Duration in PACU (Postanesthesia care unit)
time from entering PACU to exiting PACU
Early postanesthesia cognitive recovery
evaluated by Short Orientation Memory Concentration Test (SOMCT)
Dural tension
evaluated using a 4-point scale after bone flap removal.
Quality of anesthesia recovery
assessed by quality of recovery-15 scale (QoR-15)
Anesthesia expenses
Total cost of anesthesia

Full Information

First Posted
December 12, 2020
Last Updated
October 25, 2021
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04691128
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supratentorial Tumor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desflurane inhalational anesthesia
Arm Type
Experimental
Arm Title
Propofol total intravenous anesthesia
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
inhalational anesthesia
Intervention Description
After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
TIVA, total intravenous anesthesia
Intervention Description
After induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil
Primary Outcome Measure Information:
Title
Proportion of satisfactory brain relaxation
Description
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
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
Emergence time
Description
from drug discontinuation to eye opening
Time Frame
from drug discontinuation to eye opening, assessed up to 1 hours
Title
Extubation time
Description
from drug discontinuation to tracheal extubation
Time Frame
from drug discontinuation to tracheal extubation, assessed up to 1 hours
Title
Postoperative complications
Description
incidence of hypoxemia, hypotension, hypertension, tachycardia, bradycardia, agitation, shivering.
Time Frame
from drug discontinuation to discharge from PACU (Postanesthesia care unit), assessed up to 3 hours
Title
Postoperative pain and postoperative nausea and vomiting (PONV)
Description
evaluated by Visual Analogue Score(VAS).
Time Frame
during the PACU stay and postoperative day 1.
Title
Duration in PACU (Postanesthesia care unit)
Description
time from entering PACU to exiting PACU
Time Frame
from entering PACU to exiting PACU, an expected average of 1 hour
Title
Early postanesthesia cognitive recovery
Description
evaluated by Short Orientation Memory Concentration Test (SOMCT)
Time Frame
at 15, 30min after tracheal extubation
Title
Dural tension
Description
evaluated using a 4-point scale after bone flap removal.
Time Frame
during surgery
Title
Quality of anesthesia recovery
Description
assessed by quality of recovery-15 scale (QoR-15)
Time Frame
at postoperative day 1
Title
Anesthesia expenses
Description
Total cost of anesthesia
Time Frame
at postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China

12. IPD Sharing Statement

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Desflurane and Brain Relaxation in Craniotomy

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