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

NCT04329585 | Unknown

• 1 other identifier: 201911072MIND
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Moderate Sedation; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

GABA antagonist

EXPERIMENTAL

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

Drug: flumazenil

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

flumazenil DRUG

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

GABA antagonist

Placebos DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or II
• plan to do colonoscopy

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

National Taiwan University Cancer Center

Taipei, 106, Taiwan

RECRUITING

MeSH Terms

Interventions

Flumazenil

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Ying-Tzu Li, MD

CONTACT

00886919086631; B94401037@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 1, 2020
• Study Start: March 25, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2022
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)