NCT05823454

Brief Summary

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

2.9 years

First QC Date

March 5, 2023

Last Update Submit

July 30, 2024

Conditions

Consciousness Disorder

Keywords

Prolonged Disorders of ConsciousnessPropofolBrain Functional connectivityElectroencephalography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Cortical Connectivity

    During the trial(up to 3 hours for each subject)

  • Derived quantitative indicators

    During the trial(up to 3 hours for each subject)

  • Characteristics of sleep

    During the trial(up to 24 hours for each subject)

  • Dynamic Patterns of Cortical Connectivity

    During the trial(up to 3 hours for each subject)

  • Rate of patients recovered consciousness after surgery

    During the trial(through study completion, 180 days)

Study Arms (5)

Propofol

Intravenous infusion

Drug: Different drug dosage

Dexmedetomidine

Intravenous infusion

Drug: Different drug dosage

Esketamine

Intravenous infusion

Drug: Different drug dosage

Sevoflurane

Inhalation anesthesia

Drug: Different drug dosage

Remifentanil

Intravenous infusion

Drug: Different drug dosage

Interventions

Different drug dosageDRUG

Choice of Anesthesia

DexmedetomidineEsketaminePropofolRemifentanilSevoflurane

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic disorders of consciousness

You may qualify if:

  • Age 18 - 65 years old, native Chinese speaker, dextromanuality;
  • Chronic disorder of consciousness;
  • Spinal cord electrical stimulator implantation under general anesthesia;
  • Signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 5, 2023

First Posted

April 21, 2023

Study Start

September 30, 2022

Primary Completion

September 1, 2025

Study Completion

March 1, 2026

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)