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

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.

Study Overview

• Status: Unknown
• Conditions: Colonoscopy; Moderate Sedation
• Intervention / Treatment: Drug: flumazenil; Drug: Placebos

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Ying-Tzu Li, MD; Phone Number: 00886919086631; Email: B94401037@ntu.edu.tw
  • Taipei, Taiwan, 106
    • Recruiting
    • National Taiwan University Cancer Center
    • Contact: Ya-Jung Cheng, Prof; Email: chengyj@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I or II
• plan to do colonoscopy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 25, 2020
• Primary Completion (ANTICIPATED): March 31, 2021
• Study Completion (ANTICIPATED): March 31, 2022

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (ACTUAL): April 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents; GABA Modulators; GABA Agents; Antidotes; Flumazenil
• Other Study ID Numbers: 201911072MIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No