Clinical trial NCT06389344: Effect of Esketamine on Conscious State in Patients With pDoC
Official title: Effect of Esketamine on Conscious State in Patients With Prolonged Disorders of Consciousness#a Prospective, Randomized, Exploratory Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esketamine
Consciousness Disorders
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 116
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Coma recovery scale-revised(CRS-R)
timeFrame: 3±1 day after surgery
Secondary outcomes:
measure: Coma recovery scale-revised(CRS-R)
timeFrame: 1,3,6 months after surgery
measure: Full Outline of UnResponsiveness(FOUR)
timeFrame: 3±1 day, 1,3,6 months after surgery
measure: Glasgow coma scale(GCS)
timeFrame: 3±1 day, 1,3,6 months after surgery
measure: Original EEG
timeFrame: during surgery and 3±1 day after surgery
measure: Patient state index(PSI)
timeFrame: during surgery and 3±1 day after surgery
measure: Power spectral density
timeFrame: during surgery and 3±1 day after surgery
measure: Burst-suppression ratio
timeFrame: during surgery and 3±1 day after surgery
measure: Spectral edge frequency
timeFrame: during surgery and 3±1 day after surgery
measure: The incidence of perioperative adverse events
timeFrame: 3±1 day, 1,3,6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References: