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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05352685
Enrollment
60
Registered
2022-04-29
Start date
2022-05-18
Completion date
2024-09-30
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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.

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The amplitude of auditory event-related potentialDuring the trial(up to 3 hours for each subject)The amplitude of MMN and P300
The latency of auditory event-related potentialDuring the trial(up to 3 hours for each subject)The latency of MMN and P300

Secondary

MeasureTime frameDescription
Brain network functional connectivityDuring 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026