GABA Antagonist to Improve Reversal of Anesthesia With High-density EEG Surveillance

Not Applicable

• Conditions: Colonoscopy; Moderate Sedation
• Interventions: Drug: Placebos; Drug: flumazenil

• Registration Number: NCT04329585
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-25
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-30
• Last Update Submitted: 2020-03-30
• Study First Posted: 2020-04-01
• Last Update Posted: 2020-04-01
• Primary Completion: 2021-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA I or II
• plan to do colonoscopy

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Exclusion Criteria

• existed CNS disease or injuries
• known allergy to propofol, midazolam or alfentanil

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	In the end of the experiment, the same volume of normal saline is given to the participant.
GABA antagonist	flumazenil	In the end of the experiment, 0.2mg of flumazenil(GABA antagonist) is given to the participant.

Primary Outcome Measures

Name	Time	Method
The characteristic differences in EEG	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.

Trial Locations

Locations (2)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Cancer Center; 🇨🇳 Taipei, Taiwan