Consciousness Disorders, Esketamine
Conditions
Brief summary
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.
Interventions
DRUGEsketamine
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.
DRUGnormal saline
Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1.16-65 years old 2.Native Chinese language 3.pDoC after acquired brain injury 4.Scheduled to undergo surgery 5.Signed informed consent
Exclusion criteria
1. Continuous sedation treatment was carried out within 72 hours before the study 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coma recovery scale-revised(CRS-R) | 3±1 day after surgery | The CRS-R ranges from 0 to 23, with a higher score indicating a better state of consciousness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Full Outline of UnResponsiveness(FOUR) | 3±1 day, 1,3,6 months after surgery | The FOUR ranges from 0 to 16, with a higher score indicating a better state of consciousness. |
| Glasgow coma scale(GCS) | 3±1 day, 1,3,6 months after surgery | The GCS ranges from 3 to 15,with a higher score indicating a better state of consciousness. |
| Original EEG | during surgery and 3±1 day after surgery | — |
| Patient state index(PSI) | during surgery and 3±1 day after surgery | — |
| Coma recovery scale-revised(CRS-R) | 1,3,6 months after surgery | The CRS-R ranges from 0 to 23,with a higher score indicating a better state of consciousness. |
| Burst-suppression ratio | during surgery and 3±1 day after surgery | — |
| Spectral edge frequency | during surgery and 3±1 day after surgery | — |
| The incidence of perioperative adverse events | 3±1 day, 1,3,6 months after surgery | — |
| Power spectral density | during surgery and 3±1 day after surgery | — |
Countries
China
Contacts
Primary ContactRuquan Han, M.D
Outcome results
None listed