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

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

Study Overview

• Status: Recruiting
• Conditions: Consciousness Disorder
• Intervention / Treatment: Drug: Different drug dosage

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100070
    • Recruiting
    • Beijing Tiantan Hospital, Capital Medical University
    • Contact: Ruquan Han, M.D., Ph.D; Phone Number: 8610-59976660; Email: ruquan.han@gmail.com
    • Principal Investigator: Ruquan Han, M.D., Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with chronic disorders of consciousness

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical Connectivity	Characteristics of the weighted phase lag index in patients with chronic consciousness	During the trial(up to 3 hours for each subject)
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)
Characteristics of sleep	Characteristics of sleep cycle in patients with chronic disorders of consciousness	During the trial(up to 24 hours for each subject)
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)
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)

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Propofol; Electroencephalography; Prolonged Disorders of Consciousness; Brain Functional connectivity
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: ywn20220929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No