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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05823454
Other study ID # ywn20220929
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 30, 2022
Est. completion date March 1, 2026

Study information

Verified date June 2023
Source Beijing Tiantan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Different drug dosage
Choice of Anesthesia

Locations

Country Name City State
China Beijing Tiantan Hospital, Capital Medical University Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary EEG Spectral Characteristics Characteristics of EEG power spectrum(for 1-30 Hz) in patients with chronic consciousness disorder under different doses of drugs During the trial(up to 3 hours for each subject)
Secondary Cortical Connectivity Characteristics of the weighted phase lag index in patients with chronic consciousness During the trial(up to 3 hours for each subject)
Secondary Derived quantitative indicators Characteristics of EEG derived quantitative indicators with chronic consciousness disorder during anesthesia recovery During the trial(up to 3 hours for each subject)
Secondary Characteristics of sleep Characteristics of sleep cycle in patients with chronic disorders of consciousness During the trial(up to 24 hours for each subject)
Secondary Dynamic Patterns of Cortical Connectivity The time-frequency characteristics of the weighted phase lag index in patients with chronic disorders of consciousness During the trial(up to 3 hours for each subject)
Secondary Rate of patients recovered consciousness after surgery Rate of patients recovered consciousness 30 days, 90 days, 180 days after surgery During the trial(through study completion, 180 days)
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