Examining brain connectivity during propofol sedation in patients with consciousness disorders
Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness Based on Electroencephalogram and Event-related Potential
This study is testing how different amounts of propofol sedation affect brain connections in patients who have trouble with consciousness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05823454 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the brain network connections specific to consciousness during propofol sedation in patients with prolonged disorders of consciousness. Utilizing electroencephalography and auditory event-related potentials, the study aims to understand how different dosages of propofol affect brain connectivity. Participants will be monitored for their brain activity while undergoing sedation, providing insights into the relationship between sedation and consciousness disorders.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with chronic disorders of consciousness who can provide informed consent.
Not a fit: Patients with recent sedation, significant brain injuries, or other severe medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of consciousness disorders and improve sedation practices for affected patients.
How similar studies have performed: While there have been studies on sedation and consciousness, this specific approach using propofol and brain connectivity analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Beijing Tiantan Hospital, Capital Medical University — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.