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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Propofol Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy volunteers<br> | Drug: Propofol Injection<br>* 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.<br>|
| Experimental: supratentorial glioma patients<br> | Drug: Propofol Injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain network functional connectivity | 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) |