Effect of Esketamine on Conscious State in Patients With pDoC
NCT ID: NCT06389344
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
116 participants
INTERVENTIONAL
2024-05-20
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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esketamine
Esketamine ( 50mg, dissolved in 50ml normal saline ) 0.3mg / kg will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
Esketamine
Esketamine ( 50mg, dissolved in 50ml normal saline ) 0.3mg / kg will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
normal saline
Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
normal saline
Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
Interventions
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Esketamine
Esketamine ( 50mg, dissolved in 50ml normal saline ) 0.3mg / kg will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
normal saline
Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
16 Years
65 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Ruquan Han
Professor
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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lk20240401
Identifier Type: -
Identifier Source: org_study_id
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