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RecruitingNCT05352685Updated Nov 1, 2023

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

An interventional study of Propofol Injection in Propofol, Glioma and Auditory Event-related Potential (AERP), sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

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

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03

In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's planned enrollment of 60 is above the median of 32 across 1,065 interventional studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Healthy volunteers

    Drug: Propofol Injection

  • Experimental
    supratentorial glioma patients

    Drug: Propofol Injection

Interventions

  • DrugPropofol 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.

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What researchers measure

Primary outcomes

  1. The amplitude of auditory event-related potential

    The amplitude of MMN and P300

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

  2. The latency of auditory event-related potential

    The latency of MMN and P300

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

Secondary outcomes

  1. 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

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

07

Study locations

1 of 1 sites recruiting
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing 100070, China
    • Ruquan Han, M.D., Ph.D · Contact · ruquan.han@gmail.com · 8610-59976660
    • Ruquan Han, M.D., Ph.D · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05352685
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Ruquan Han (Head of anesthesiology, Principal Investigator, Clinical Professor, Beijing Tiantan Hospital) — Principal investigator
First posted
Apr 29, 2022
Start date
May 18, 2022
Primary completion
Sep 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Nov 1, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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