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

October 30, 2023 updated by: Ruquan Han, Beijing Tiantan Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Ruquan Han, M.D., Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy volunteers
Drug: Propofol Injection
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.
Experimental: supratentorial glioma patients
Drug: Propofol Injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amplitude of auditory event-related potential
Time Frame: During the trial(up to 3 hours for each subject)
The amplitude of MMN and P300
During the trial(up to 3 hours for each subject)
The latency of auditory event-related potential
Time Frame: During the trial(up to 3 hours for each subject)
The latency of MMN and P300
During the trial(up to 3 hours for each subject)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain network functional connectivity
Time Frame: During the trial(up to 3 hours for each subject)
Using coherence ; phase slope index(PSI); phase locking value(PLV）;phase lag index(PLI）to evaluate the brain network functional connectivity of subjects
During the trial(up to 3 hours for each subject)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2022

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 23, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wxx19950421

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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