GABA Antagonist to Improve Reversal of Anesthesia: a Double Blind Study With High-density EEG Surveillance
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The characteristic differences in EEG
研究概览
简要总结
For recent years, patients are more likely to accept sedation during endoscopic examination due to better quality and experience. Modest anesthetic state for different kind of procedure is important, but it is also not easy to maintain in the same state all the time. Thus, to prevent awareness during the procedure, monitoring the brain state is an important issue. Traditionally, anesthesiologists assess patients' brain state from heart rate, blood pressure and muscle tone. All these vital signs are indirect hint for the real brain state. Thus, electroencephalogram(EEG) was considered to be potential tool to directly monitor our brain during anesthesia. In 1937, EEG study was started in anesthetic patients. Until 1994, Bispectral Index, the first commercialized processed EEG monitor, was published for intra-operative brain state assessment. To perform EEG study on a surgical patient is not easy due to the complex circuits and lots of interrupts during the procedure. This might be the reason why most of the EEG studies under anesthesia are collecting from healthy volunteers. It takes longer preparation, better team cooperation, and support from hospital to start this study in endoscopy room.
The investigators would like to start from a preliminary study, 5 patients in each groups, and collect the EEG during peri-endoscopic period. The sedation steps follow the routine protocol of our practice. Flumazenil and placebo are given to the groups separately on the end of the examination. From this study, further understanding of human brain during sedation especially in such short periods is expected. And furthermore, to give safer and more comfortable anesthetic experience for the patients.
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
- Double (Participant, Investigator)
盲法说明
It's double-blind study. We make every participant an envelope in which a randomized result of GABA antagonist or normal saline is declared to the care provider during the colonoscopy. The participant and the investigator are not aware of the medication.
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or II
- •plan to do colonoscopy
排除标准
- •existed CNS disease or injuries
- •known allergy to propofol, midazolam or alfentanil
研究组 & 干预措施
GABA antagonist
In the end of the experiment, 0.2mg of flumazenil(GABA antagonist) is given to the participant.
干预措施: flumazenil (Drug)
Placebo
In the end of the experiment, the same volume of normal saline is given to the participant.
干预措施: Placebos (Drug)
结局指标
主要结局
The characteristic differences in EEG
时间窗: Start from the colonoscopy to 30 minutes after the end of colonoscopy.
Whether the reversal of GABA antagonist is able to make EEG recover to the awake status.
次要结局
未报告次要终点
