Actively Recruiting
Effect of Esketamine on Conscious State in Patients With pDoC
Led by Beijing Tiantan Hospital · Updated on 2024-07-30
116
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn about the effect of intraoperative infusion of subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness under sevoflurane anesthesia. Participants will be patients with prolonged disorders of consciousness undergoing surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg esketamine or saline will be infused will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. Coma recovery scale-revised, Glasgow coma scale, Full Outline of UnResponsiveness scores, SedLine multi-channel electroencephalogram and perioperative adverse events after surgery will be investigated.
CONDITIONS
Official 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 speakers
- Diagnosed with prolonged disorders of consciousness after acquired brain injury
- Scheduled for surgery
- Signed informed consent
You will not qualify if you...
- Continuous sedation treatment within 72 hours before the study
- Airway narrowing or severe breathing problems
- Serious heart problems including unstable coronary syndrome, congestive heart failure with left ventricular ejection fraction less than 50%, elevated BNP, severe arrhythmia, or severe valvular disease
- Severe lung problems such as pulmonary heart disease or chronic obstructive pulmonary disease
- Severe kidney problems with creatinine clearance less than 30 ml/min or glomerular filtration rate less than 30 ml/min/1.73m2
- Allergy to sedative drugs
- Presence of other mental or nervous system diseases
- Other conditions making participation unsuitable
AI-Screening
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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
CONTACT
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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