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

NCT ID: NCT05352685

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

Group Type: ACTIVE_COMPARATOR

Propofol Injection

Intervention Type: 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.

supratentorial glioma patients

Group Type: EXPERIMENTAL

Propofol Injection

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Head of anesthesiology, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ruquan Han, M.D., Ph.D

Role: primary

ruquan.han@gmail.com

8610-59976660

Other Identifiers

wxx19950421

Identifier Type: -

Identifier Source: org_study_id