Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04329585
Enrollment
60
Registered
2020-04-01
Start date
2020-03-25
Completion date
2022-03-31
Last updated
2020-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Moderate Sedation

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.

Interventions

DRUGflumazenil

EEG is observed in both groups to compare the difference between two groups.

DRUGPlacebos

Placebo is the normal saline, which is given in the controlled group.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ASA I or II * plan to do colonoscopy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The characteristic differences in EEGStart 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.

Countries

Taiwan

Contacts

Primary ContactYing-Tzu Li, MD
B94401037@ntu.edu.tw00886919086631

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026