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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04329585

Collaborator

(none)

Enrollment

Locations

Arms

24.2

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Moderate Sedation Colonoscopy	Drug: flumazenil Drug: Placebos	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 25, 2020

Anticipated Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GABA antagonist In the end of the experiment, 0.2mg of flumazenil(GABA antagonist) is given to the participant.	Drug: flumazenil EEG is observed in both groups to compare the difference between two groups.
Placebo Comparator: Placebo In the end of the experiment, the same volume of normal saline is given to the participant.	Drug: Placebos Placebo is the normal saline, which is given in the controlled group.

Arm

Intervention/Treatment

Experimental: GABA antagonist

In the end of the experiment, 0.2mg of flumazenil(GABA antagonist) is given to the participant.

Drug: flumazenil

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

Placebo Comparator: Placebo

In the end of the experiment, the same volume of normal saline is given to the participant.

Drug: Placebos

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA I or II
plan to do colonoscopy

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100
2	National Taiwan University Cancer Center	Taipei		Taiwan	106

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT04329585

Other Study ID Numbers:

201911072MIND

First Posted:

Apr 1, 2020

Last Update Posted:

Apr 1, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Flumazenil

Study Results

No Results Posted as of Apr 1, 2020