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NCT Number: NCT05823454

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 Electroencephalography and Auditory Event-related Potentials

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

Location status: Recruiting

Location contact

Ruquan Han, M.D., Ph.D

CONTACT

[email protected]

8610-59976660

Ruquan Han, M.D., Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Different drug dosage

Drug

Choice of Anesthesia

Primary outcomes

  1. EEG Spectral Characteristics

    Time frame: 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 outcomes

  1. Cortical Connectivity

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

    Characteristics of the weighted phase lag index in patients with chronic consciousness

  2. Derived quantitative indicators

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

    Characteristics of EEG derived quantitative indicators with chronic consciousness disorder during anesthesia recovery

  3. Characteristics of sleep

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

    Characteristics of sleep cycle in patients with chronic disorders of consciousness

  4. Dynamic Patterns of Cortical Connectivity

    Time frame: 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

  5. Rate of patients recovered consciousness after surgery

    Time frame: During the trial(through study completion, 180 days)

    Rate of patients recovered consciousness 30 days, 90 days, 180 days after surgery

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 21, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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