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

Not Applicable

Recruiting

• Conditions: Propofol; Auditory Event-related Potential (AERP); Electroencephalogram (EEG); Glioma; Brain Network Connectivity
• Interventions: Drug: Propofol Injection

• Registration Number: NCT05352685
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-23
• Study First Posted: 2022-04-29
• Study Start: 2022-05-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Propofol Injection	-
supratentorial glioma patients	Propofol Injection	-

Primary Outcome Measures

Name	Time	Method
The amplitude of auditory event-related potential	During the trial(up to 3 hours for each subject)	The amplitude of MMN and P300
The latency of auditory event-related potential	During the trial(up to 3 hours for each subject)	The latency of MMN and P300

Secondary Outcome Measures

Name	Time	Method
Brain network functional connectivity	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

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China