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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05823454

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Consciousness Disorder	Drug: Different drug dosage

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Propofol Intravenous infusion	Drug: Different drug dosage Choice of Anesthesia
Dexmedetomidine Intravenous infusion	Drug: Different drug dosage Choice of Anesthesia
Esketamine Intravenous infusion	Drug: Different drug dosage Choice of Anesthesia
Sevoflurane Inhalation anesthesia	Drug: Different drug dosage Choice of Anesthesia
Remifentanil Intravenous infusion	Drug: Different drug dosage Choice of Anesthesia

Outcome Measures

Primary Outcome Measures

EEG Spectral Characteristics [During 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 Outcome Measures

Cortical Connectivity [During the trial(up to 3 hours for each subject)]
Characteristics of the weighted phase lag index in patients with chronic consciousness
Derived quantitative indicators [During the trial(up to 3 hours for each subject)]
Characteristics of EEG derived quantitative indicators with chronic consciousness disorder during anesthesia recovery
Characteristics of sleep [During the trial(up to 24 hours for each subject)]
Characteristics of sleep cycle in patients with chronic disorders of consciousness
Dynamic Patterns of Cortical Connectivity [During 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 surgery [During the trial(through study completion, 180 days)]
Rate of patients recovered consciousness 30 days, 90 days, 180 days after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.