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

NCT04329585 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-04-01

No results posted yet for this study

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

Interventions

DRUG

flumazenil

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

DRUG

Placebos

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-25
Primary Completion
2021-03-31
Completion
2022-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04329585 on ClinicalTrials.gov