Status unknownNCT05823454Updated Aug 1, 2024

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

An observational study in Consciousness Disorder, sponsored by Beijing Tiantan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Beijing Tiantan Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Other
Enrollment: 200
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Conditions studied

Consciousness Disorder

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Consciousness Disorders 244

Keywords

Prolonged Disorders of Consciousness
Propofol
Brain Functional connectivity
Electroencephalography

In context

Consciousness Disorders

244 studies on the registry are indexed under Consciousness Disorders; 104 are open to participants now.

This study's planned enrollment of 200 is above the median of 79 across 86 observational studies indexed under Consciousness Disorders.

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Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 481 studies on the registry; 287 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

Patients with chronic disorders of consciousness

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Observational model: Cohort
Time perspective: Other
Enrollment: 200 participants (estimated)
Target follow-up: 6 Months
Patient registry: Yes

Groups and cohorts

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

DrugDifferent drug dosage
Choice of Anesthesia

What researchers measure

Primary outcomes

EEG Spectral Characteristics
Characteristics of EEG power spectrum(for 1-30 Hz) in patients with chronic consciousness disorder under different doses of drugs
Time frame: During the trial(up to 3 hours for each subject)

Secondary outcomes

Cortical Connectivity
Characteristics of the weighted phase lag index in patients with chronic consciousness
Time frame: 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
Time frame: During the trial(up to 3 hours for each subject)
Characteristics of sleep
Characteristics of sleep cycle in patients with chronic disorders of consciousness
Time frame: 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
Time frame: 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
Time frame: During the trial(through study completion, 180 days)

Study locations

1 of 1 sites recruiting

Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070, China
- Ruquan Han, M.D., Ph.D · Contact · ruquan.han@gmail.com · 8610-59976660
- Ruquan Han, M.D., Ph.D · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05823454
Lead sponsor: Beijing Tiantan Hospital
Responsible party: Ruquan Han (Professor, Beijing Tiantan Hospital) — Principal investigator
First posted: Apr 21, 2023
Start date: Sep 30, 2022
Primary completion: Sep 1, 2025 (estimated)
Completion: Mar 1, 2026 (estimated)
Last update: Aug 1, 2024

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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