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Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness

Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness Based on Electroencephalogram and Event-related Potential

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05823454
Enrollment
200
Registered
2023-04-21
Start date
2022-09-30
Completion date
2026-03-01
Last updated
2024-08-01

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

Conditions

Consciousness Disorder

Keywords

Prolonged Disorders of Consciousness, Propofol, Brain Functional connectivity, Electroencephalography

Brief summary

Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness based on Electroencephalography and Auditory Event-related Potentials

Interventions

DRUGDifferent drug dosage

Choice of Anesthesia

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18 - 65 years old, native Chinese speaker, dextromanuality; * Chronic disorder of consciousness; * Spinal cord electrical stimulator implantation under general anesthesia; * Signed informed consent.

Exclusion criteria

* Continuous sedation was administered within 72 hours prior to the study; * Open head injury, parenchymatectomy and other damage of brain structural integrity; * The intracranial compliance decreased due to hydrocephalus and swelling; * Known hearing impairment; * Airway stenosis and various causes of severe ventilation or ventilation dysfunction; * Known or suspected cardiac dysfunction; * Allergic to intravenous general anesthetics; * Associated with other mental or neurological diseases; * Other reasons are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frameDescription
EEG Spectral CharacteristicsDuring the trial(up to 3 hours for each subject)Characteristics of EEG power spectrum(for 1-30 Hz) in patients with chronic consciousness disorder under different doses of drugs

Secondary

MeasureTime frameDescription
Cortical ConnectivityDuring the trial(up to 3 hours for each subject)Characteristics of the weighted phase lag index in patients with chronic consciousness
Derived quantitative indicatorsDuring the trial(up to 3 hours for each subject)Characteristics of EEG derived quantitative indicators with chronic consciousness disorder during anesthesia recovery
Characteristics of sleepDuring the trial(up to 24 hours for each subject)Characteristics of sleep cycle in patients with chronic disorders of consciousness
Dynamic Patterns of Cortical ConnectivityDuring the trial(up to 3 hours for each subject)The time-frequency characteristics of the weighted phase lag index in patients with chronic disorders of consciousness
Rate of patients recovered consciousness after surgeryDuring the trial(through study completion, 180 days)Rate of patients recovered consciousness 30 days, 90 days, 180 days after surgery

Countries

China

Outcome results

None listed

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