Effect of esketamine on consciousness in patients with prolonged disorders of consciousness
Effect of Esketamine on Conscious State in Patients With Prolonged Disorders of Consciousness#a Prospective, Randomized, Exploratory Study
This study is testing if a low dose of esketamine can help improve awareness in patients with prolonged disorders of consciousness during surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06389344 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a subanesthetic dose of esketamine on the conscious state of patients with prolonged disorders of consciousness (pDoC) during surgery. Participants will receive either esketamine or saline intravenously after tracheal intubation while under sevoflurane anesthesia. The study will assess various scales to evaluate consciousness recovery and monitor any perioperative adverse events. The goal is to determine if esketamine can enhance conscious awareness in these patients.
Who should consider this trial
Good fit: Ideal candidates are Chinese-speaking individuals aged 16-65 with prolonged disorders of consciousness due to acquired brain injury who are scheduled for surgery.
Not a fit: Patients with severe cardiac, pulmonary, or renal dysfunction, or those who have undergone continuous sedation treatment within 72 hours prior to the study may not benefit.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to improve consciousness in patients with prolonged disorders of consciousness.
How similar studies have performed: While the use of esketamine in this context is novel, similar studies exploring consciousness recovery in patients with disorders of consciousness have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.16-65 years old 2.Native Chinese language 3.pDoC after acquired brain injury 4.Scheduled to undergo surgery 5.Signed informed consent Exclusion Criteria: 1. Continuous sedation treatment was carried out within 72 hours before the study 2. Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons 3. Known or suspected to have serious cardiac, pulmonary and renal dysfunction 1)Severe cardiac dysfunction: a. unstable coronary syndrome b. Congestive heart failure: left ventricular ejection fraction less than 50%, elevated BNP c.Severe arrhythmia d. History of severe valvular disease 2)Severe pulmonary dysfunction: a. history of pulmonary heart disease b. History of chronic obstructive pulmonary disease 3)Severe renal dysfunction: a. Endogenous creatinine clearance (Ccr) less than 30ml/min b. The glomerular filtration rate (GFR) was less than 30ml/min•1.73m2 4. Allergic history of sedative drugs 5. Combined with other mental or nervous system diseases 6. Other reasons are not suitable for this study.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ruquan Han, M.D
- Email: ruquan.han@ccmu.edu.cn
- Phone: 8610-59976660
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.