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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
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.
Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGComa 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 surgery
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 surgery
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 surgery
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 surgery
Original EEG
Time frame: during surgery and 3±1 day after surgery
Patient state index(PSI)
Time frame: during surgery and 3±1 day after surgery
Power spectral density
Time frame: during surgery and 3±1 day after surgery
Burst-suppression ratio
Time frame: during surgery and 3±1 day after surgery
Spectral edge frequency
Time frame: during surgery and 3±1 day after surgery
The incidence of perioperative adverse events
Time frame: 3±1 day, 1,3,6 months after surgery
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