Consciousness DisorderNCT05823454
Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness
An observational study of Consciousness Disorder, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness based on Electroencephalography and Auditory Event-related Potentials Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Consciousness Disorder
- What is being tested?
- Different drug dosage
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 1 Mar 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic disorders of consciousness
Who may be able to join
- Age 18 - 65 years old, native Chinese speaker, dextromanuality;
- Chronic disorder of consciousness;
- Spinal cord electrical stimulator implantation under general anesthesia;
- Signed informed consent.
Who cannot join
- 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;
Show all 9Show fewer
- Allergic to intravenous general anesthetics;
- Associated with other mental or neurological diseases;
- Other reasons are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
Ruquan Han, M.D., Ph.D
About this study
Official title: 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
- Conditions
- Consciousness Disorder
- Being tested
- Different drug dosage
- Keywords
- Prolonged Disorders of Consciousness, Propofol, Brain Functional connectivity, Electroencephalography
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different drug dosageDrug
Choice of Anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Intravenous infusion Receives: Drug: Different drug dosage | |
| Dexmedetomidine | Intravenous infusion Receives: Drug: Different drug dosage | |
| Esketamine | Intravenous infusion Receives: Drug: Different drug dosage | |
| Sevoflurane | Inhalation anesthesia Receives: Drug: Different drug dosage | |
| Remifentanil | Intravenous infusion Receives: Drug: Different drug dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Spectral Characteristics
Characteristics of EEG power spectrum(for 1-30 Hz) in patients with chronic consciousness disorder under different doses of drugs
Measured: During the trial(up to 3 hours for each subject)
Secondary outcomes (5)
Cortical Connectivity
Characteristics of the weighted phase lag index in patients with chronic consciousness
Measured: 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
Measured: During the trial(up to 3 hours for each subject)
Characteristics of sleep
Characteristics of sleep cycle in patients with chronic disorders of consciousness
Measured: 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
Measured: 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
Measured: During the trial(through study completion, 180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start30 Sep 2022
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisorderStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823454
- Sponsor's protocol ID
- ywn20220929
- Status last verified
- Jul 2024
- First submitted
- 5 Mar 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness Based on Electroencephalogram and Event-related Potential
- ClinicalTrials.gov ID
- NCT05823454
- Acronym / sponsor ID
- ywn20220929
- Conditions
- Consciousness Disorder
- Keywords
- Prolonged Disorders of Consciousness, Propofol, Brain Functional connectivity, Electroencephalography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness based on Electroencephalography and Auditory Event-related Potentials
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Propofol | – | Drug: Different drug dosageIntravenous infusion |
| Dexmedetomidine | – | Drug: Different drug dosageIntravenous infusion |
| Esketamine | – | Drug: Different drug dosageIntravenous infusion |
| Sevoflurane | – | Drug: Different drug dosageInhalation anesthesia |
| Remifentanil | – | Drug: Different drug dosageIntravenous infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic disorders of consciousness
Key inclusion criteria (4 listed)
- Age 18 - 65 years old, native Chinese speaker, dextromanuality;
- Chronic disorder of consciousness;
- Spinal cord electrical stimulator implantation under general anesthesia;
- Signed informed consent.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different drug dosageChoice of Anesthesia | Drug | Dexmedetomidine, Esketamine, Propofol, Remifentanil, Sevoflurane |
Primary outcome
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
5 secondary outcomes
Cortical Connectivity
Time frame: During the trial(up to 3 hours for each subject)
Derived quantitative indicators
Time frame: During the trial(up to 3 hours for each subject)
Characteristics of sleep
Time frame: During the trial(up to 24 hours for each subject)
Dynamic Patterns of Cortical Connectivity
Time frame: During the trial(up to 3 hours for each subject)
Rate of patients recovered consciousness after surgery
Time frame: During the trial(through study completion, 180 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Consciousness Disorder
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consciousness Disorder, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Spectral Characteristics (time frame: During the trial(up to 3 hours for each subject)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.