Effect of Esketamine on Conscious State in Patients With pDoC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-65
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Continuous sedation treatment was carried out within 72 hours before the study
Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons
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
Allergic history of sedative drugs
Trial design
Design model
Parallel
Treatments tested in this trial
Esketamine
DrugEsketamine ( 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
DrugSame amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: esketamineExperimental treatment 1 intervention
Group B: normal salinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Coma recovery scale-revised(CRS-R)
The CRS-R ranges from 0 to 23, with a higher score indicating a better state of consciousness.
Time frame
3±1 day after surgerySecondary outcomes
1
Coma recovery scale-revised(CRS-R)
The CRS-R ranges from 0 to 23,with a higher score indicating a better state of consciousness.
Time frame
1,3,6 months after surgery2
Full Outline of UnResponsiveness(FOUR)
The FOUR ranges from 0 to 16, with a higher score indicating a better state of consciousness.
Time frame
3±1 day, 1,3,6 months after surgery3
Glasgow coma scale(GCS)
The GCS ranges from 3 to 15,with a higher score indicating a better state of consciousness.
Time frame
3±1 day, 1,3,6 months after surgery4
Original EEG
Time frame
during surgery and 3±1 day after surgerySponsors and contacts
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Source ClinicalTrials.gov