Effect of Esketamine on Conscious State in Patients With Prolonged Disorders of Consciousness#a Prospective, Randomized, Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Coma recovery scale-revised(CRS-R)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.16-65 years old 2.Native Chinese language 3.pDoC after acquired brain injury 4.Scheduled to undergo surgery 5.Signed informed consent
排除标准
- •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
- •Combined with other mental or nervous system diseases
- •Other reasons are not suitable for this study.
研究组 & 干预措施
normal saline
Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
干预措施: normal saline (Drug)
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.
干预措施: Esketamine (Drug)
结局指标
主要结局
Coma recovery scale-revised(CRS-R)
时间窗: 3±1 day after surgery
The CRS-R ranges from 0 to 23, with a higher score indicating a better state of consciousness.
次要结局
- Coma recovery scale-revised(CRS-R)(1,3,6 months after surgery)
- Glasgow coma scale(GCS)(3±1 day, 1,3,6 months after surgery)
- Original EEG(during surgery and 3±1 day after surgery)
- Patient state index(PSI)(during surgery and 3±1 day after surgery)
- Power spectral density(during surgery and 3±1 day after surgery)
- Burst-suppression ratio(during surgery and 3±1 day after surgery)
- Full Outline of UnResponsiveness(FOUR)(3±1 day, 1,3,6 months after surgery)
- The incidence of perioperative adverse events(3±1 day, 1,3,6 months after surgery)
- Spectral edge frequency(during surgery and 3±1 day after surgery)
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital