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GABA Antagonist to Improve Reversal of Anesthesia: a Double Blind Study With High-density EEG Surveillance
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.
Age
20 - 65 years
Sex
ALL
Healthy Volunteers
No
National Taiwan University Hospital
Taipei, Taiwan
National Taiwan University Cancer Center
Taipei, Taiwan
Start Date
March 25, 2020
Primary Completion Date
March 31, 2021
Completion Date
March 31, 2022
Last Updated
April 1, 2020
60
ESTIMATED participants
flumazenil
DRUG
Placebos
DRUG
Lead Sponsor
National Taiwan University Hospital
NCT07353853
NCT07355777
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