Actively Recruiting
Effect of Esketamine on Conscious State in Patients With Prolonged Disorders of Consciousness A Prospective, Randomized, Exploratory Study
Led by Beijing Tiantan Hospital · Updated on 2024-07-30
116
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effect of giving a low dose of esketamine during surgery on the consciousness of patients who have prolonged disorders of consciousness and are undergoing general anesthesia. The study focuses on patients aged 16 to 65 years with this condition, aiming to understand how esketamine affects their conscious state under sevoflurane anesthesia. This is a prospective, randomized, exploratory study led by Beijing Tiantan Hospital. Participants will receive either an intravenous infusion of esketamine at 0.3 mg/kg dissolved in saline or a placebo saline infusion. This infusion is given at a constant speed within 30 minutes after tracheal intubation or pneumatectomy fixation during surgery. There are two study groups: one receiving esketamine and the other receiving normal saline as a placebo. During and after surgery, researchers will assess patients using various tools, including the Coma Recovery Scale-Revised, Glasgow Coma Scale, Full Outline of UnResponsiveness scores, and SedLine multi-channel electroencephalogram. They will also monitor patient state indexes, power spectral density, burst-suppression ratio, spectral edge frequency, and perioperative adverse events. These assessments occur during surgery, at about 3 days after surgery, and at 1, 3, and 6 months post-surgery to track changes in consciousness and safety outcomes.
CONDITIONS
Brief Title
Effect of Esketamine on Conscious State in Patients With pDoC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 65 years
- Native Chinese language speaker
- Diagnosed with prolonged disorders of consciousness after acquired brain injury
- Scheduled to undergo surgery
- Signed informed consent to participate
You will not qualify if you...
- Received continuous sedation treatment within 72 hours before the study
- Airway stenosis or severe ventilation dysfunction
- Serious cardiac dysfunction such as unstable coronary syndrome, congestive heart failure with low ejection fraction, severe arrhythmia, or severe valvular disease
- Severe pulmonary dysfunction including pulmonary heart disease or chronic obstructive pulmonary disease
- Severe renal dysfunction with low creatinine clearance or glomerular filtration rate
- History of allergy to sedative drugs
- Presence of other mental or nervous system diseases
- Any other condition making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment during surgery
Participants receive an intravenous infusion of either esketamine or normal saline at a constant speed within 30 minutes after tracheal intubation or pneumatectomy fixation during surgery.
1 treatment visit (in-person during surgery)
Duration - Up to 6 months after surgery
Participants undergo assessments of consciousness and neurological function at multiple time points after surgery.
Visits at approximately 3 days, 1 month, 3 months, and 6 months after surgery
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
R
Ruquan Han, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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