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

Consciousness Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823454
• Other study ID #: ywn20220929
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Consciousness Disorder
• Consciousness Disorders

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)