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

Recruiting

• Conditions: Consciousness Disorder
• Interventions: Drug: Different drug dosage

• Registration Number: NCT05823454
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-30
• Study First Submitted: 2023-03-05
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-09-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Propofol	Different drug dosage	Intravenous infusion
Sevoflurane	Different drug dosage	Inhalation anesthesia
Remifentanil	Different drug dosage	Intravenous infusion
Dexmedetomidine	Different drug dosage	Intravenous infusion
Esketamine	Different drug dosage	Intravenous infusion

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Characteristics of sleep	During the trial(up to 24 hours for each subject)	Characteristics of sleep cycle 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

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China