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Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma

Primary Purpose

Propofol, Glioma, Auditory Event-related Potential (AERP)

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

About this trial

This is an interventional other trial for Propofol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 18 - 60 years old;
  2. American Society of Anesthesiologists (ASA) physical status rating I-II;
  3. Supratentorial glioma (frontal, temporal, parietal, insular ；WHO grade I-III);
  4. Native Chinese speaker;
  5. Signed informed consent.

Exclusion Criteria:

  1. Mallampati airway class≥III;
  2. BMI>30kg/m2;
  3. Combined OSAS or Stop-BANG score≥3;
  4. Hearing impairment
  5. Combined epilepsy symptoms
  6. Recurrent or multiple intracranial tumors
  7. Concomitant other psychiatric or neurological disorders
  8. Pregnancy and lactation

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy volunteers

supratentorial glioma patients

Arm Description

Outcomes

Primary Outcome Measures

The amplitude of auditory event-related potential
The amplitude of MMN and P300
The latency of auditory event-related potential
The latency of MMN and P300

Secondary Outcome Measures

Brain network functional connectivity
Using coherence ; phase slope index(PSI); phase locking value(PLV）;phase lag index(PLI）to evaluate the brain network functional connectivity of subjects

Full Information

First Posted
April 18, 2022
Last Updated
September 20, 2022
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05352685
Brief Title
Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma
Official Title
Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

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
The growth of gliomas often infiltrates important brain tissues and impairs subcortical fiber transmission, resulting in changes in global brain network connectivity. Most of the current anesthesia depth monitoring methods are based on healthy brain function population，which is difficult to reflect the sedation depth of glioma patients accurately. Therefore, this study aims to explore the characteristics of brain network connectivity in glioma patients under different sedation depths by electroencephalogram (EEG) and auditory event-related potential (AERP) methods, which may provide a research basis for sedative titration and anesthesia depth identification in glioma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Propofol, Glioma, Auditory Event-related Potential (AERP), Electroencephalogram (EEG), Brain Network Connectivity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Title
supratentorial glioma patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Propofol Injection
Intervention Description
1% propofol is used for target-controlled infusion, and gradually increase the effect concentration at 0.2ug/ml. Make the subject's sedation depth reach light sedation and deep sedation respectively. EEG data were collected during wakefulness, light sedation, deep sedation, and recovery.
Primary Outcome Measure Information:
Title
The amplitude of auditory event-related potential
Description
The amplitude of MMN and P300
Time Frame
During the trial(up to 3 hours for each subject)
Title
The latency of auditory event-related potential
Description
The latency of MMN and P300
Time Frame
During the trial(up to 3 hours for each subject)
Secondary Outcome Measure Information:
Title
Brain network functional connectivity
Description
Using coherence ; phase slope index(PSI); phase locking value(PLV）;phase lag index(PLI）to evaluate the brain network functional connectivity of subjects
Time Frame
During the trial(up to 3 hours for each subject)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 - 60 years old; American Society of Anesthesiologists (ASA) physical status rating I-II; Supratentorial glioma (frontal, temporal, parietal, insular ；WHO grade I-III); Native Chinese speaker; Signed informed consent. Exclusion Criteria: Mallampati airway class≥III; BMI>30kg/m2; Combined OSAS or Stop-BANG score≥3; Hearing impairment Combined epilepsy symptoms Recurrent or multiple intracranial tumors Concomitant other psychiatric or neurological disorders Pregnancy and lactation
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D
Phone
8610-59976660
Email
ruquan.han@gmail.com
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D

12. IPD Sharing Statement

Learn more about this trial

Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma

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