Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Recovery time
研究概览
简要总结
Esketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor different from other gamma-aminobutyric acid (GABA) receptor agonists. Recent studies showed that subanesthetic doses of ketamine not only deepen anesthesia but also accelerate recovery from isoflurane anesthesia in mice. It is necessary to verify if it applies to human. Besides inducing behavioral unresponsiveness, an optimal and important goal of general anesthesia is to prevent connected consciousness. The results of many studies support the conclusion that anesthesia-related unconsciousness is a consistent functional disconnection of lateral frontoparietal networks.The goal of this clinical trial is to learn if subanaesthetic doses of esketamine works to accelerate the recovery of consciousness from propofol anesthesia. It will also learn about the change of brain network when administrated the esketamine during propofol anesthesia. The main questions it aims to answer are:
- Does subanaesthetic doses of esketamine can accelerate recovery from propofol anaesthesia?
- What will happen to brain network connection after different doses of esketamine during propofol anesthesia?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 years to 50 years
- •Patients scheduled for elective operative hysteroscopy
- •Willing to sign informed consent
排除标准
- •Contraindications of propofol and esketamine
- •Contraindications for EEG;
- •BMI≥30 kg/m2 or BMI<18 kg/m2;
- •The MMSE scale score is lower than the normal value;
- •Alcohol or drug abuse;
- •Untreated or under-treated hypertension, hyperthyroidism, risk of increased intracranial pressure, audio-visual impairment, history of psychiatric disorders or neurological diseases, malignant tumors or other major diseases;
- •Use of other neurological drugs or drugs known to interact with propofol and esketamine in the past 2 weeks;
- •Pregnant and lactating women;
- •The operation duration is shorter than 15 minutes or longer than 60 minutes.
研究组 & 干预措施
low dose of esketamine
Drug：esketamine (0.3mg/kg)
干预措施: Esketamine (Drug)
high dose of esketamine
Drug：esketamine(0.6mg/kg)
干预措施: Esketamine (Drug)
control group
Drug：0.9% saline
干预措施: Saline (Drug)
结局指标
主要结局
Recovery time
时间窗: 2 hours
Recovery time will be defined as the time from terminating propofol administration to opening eyes to verbal stimuli (participants addressed by name) or, if necessary, mild tactile stimuli (a tap in the shoulder) every 30 seconds.
次要结局
- Explicit memory scores and implicit memory scores(2 hours)
- Patients state index(2 hours)
- Spectral edge frequency(2 hours)
- Original EEG(2 hours)
- Subjective experience report(2 hours)
- Grooved Pegboard Test points(2 hours)
- Burst suppression ratio(2 hours)
研究者
Ruquan Han
Director of Anesthesiology Department
Beijing Tiantan Hospital