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

Colonoscopy Clinical Trial

Official title:

GABA Antagonist to Improve Reversal of Anesthesia: a Double Blind Study With High-density EEG Surveillance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04329585
• Other study ID #: 201911072MIND
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: March 2020
• Source: National Taiwan University Hospital
• Contact: Ying-Tzu Li, MD
• Phone: 00886919086631
• Email: B94401037[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA I or II

• plan to do colonoscopy

Exclusion Criteria:

• existed CNS disease or injuries

• known allergy to propofol, midazolam or alfentanil

Related Conditions & MeSH terms

• Colonoscopy
• Moderate Sedation

Intervention

Drug:
• flumazenil
EEG is observed in both groups to compare the difference between two groups.
• Placebos
Placebo is the normal saline, which is given in the controlled group.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Cancer Center	Taipei
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The characteristic differences in EEG	Whether the reversal of GABA antagonist is able to make EEG recover to the awake status.	Start from the colonoscopy to 30 minutes after the end of colonoscopy.