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

NCT05352685 | Unknown

• 1 other identifier: wxx19950421
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Propofol; Glioma; Auditory Event-related Potential (AERP); Electroencephalogram (EEG); Brain Network Connectivity

Outcome Measures

Primary Outcomes (2)

• The amplitude of auditory event-related potential

  The amplitude of MMN and P300

  During the trial(up to 3 hours for each subject)

• The latency of auditory event-related potential

  The latency of MMN and P300

  During the trial(up to 3 hours for each subject)

Secondary Outcomes (1)

• Brain network functional connectivity

  During the trial(up to 3 hours for each subject)

Study Arms (2)

Healthy volunteers

ACTIVE COMPARATOR

Drug: Propofol Injection

supratentorial glioma patients

EXPERIMENTAL

Drug: Propofol Injection

Interventions

Propofol Injection DRUG

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.

Healthy volunteers; supratentorial glioma patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Propofol

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of anesthesiology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 29, 2022
• Study Start: May 18, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

CN (1)