Moderate SedationNCT04329585
GABA Antagonist to Improve Reversal of Anesthesia With High-density EEG Surveillance
A study testing flumazenil in people with Moderate Sedation and Colonoscopy, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Moderate Sedation, Colonoscopy
- What is being tested?
- flumazenil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 25 Mar 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II
- plan to do colonoscopy
Who cannot join
- existed CNS disease or injuries
- known allergy to propofol, midazolam or alfentanil
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Ying-Tzu Li, MD, 00886919086631, B94401037@ntu.edu.tw
- Recruiting
National Taiwan University Cancer Center
Taipei, 106
Ya-Jung Cheng, Prof, chengyj@ntu.edu.tw
About this study
Official title: 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.
- Conditions
- Moderate Sedation, Colonoscopy
- Being tested
- flumazenil, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flumazenilDrug
EEG is observed in both groups to compare the difference between two groups.
PlacebosDrug
Placebo is the normal saline, which is given in the controlled group.
| Study group | Role | What they receive |
|---|---|---|
| GABA antagonist | Experimental | In the end of the experiment, 0.2mg of flumazenil(GABA antagonist) is given to the participant. Receives: Drug: flumazenil |
| Placebo | Placebo comparator | In the end of the experiment, the same volume of normal saline is given to the participant. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
The characteristic differences in EEG
Whether the reversal of GABA antagonist is able to make EEG recover to the awake status.
Measured: Start from the colonoscopy to 30 minutes after the end of colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start25 Mar 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate SedationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329585
- Sponsor's protocol ID
- 201911072MIND
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GABA Antagonist to Improve Reversal of Anesthesia: a Double Blind Study With High-density EEG Surveillance
- ClinicalTrials.gov ID
- NCT04329585
- Acronym / sponsor ID
- 201911072MIND
- Conditions
- Moderate Sedation, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GABA antagonist | Experimental | Drug: flumazenilIn the end of the experiment, 0.2mg of flumazenil(GABA antagonist) is given to the participant. |
| Placebo | Placebo comparator | Drug: PlacebosIn the end of the experiment, the same volume of normal saline is given to the participant. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I or II
- plan to do colonoscopy
Key exclusion criteria (2 listed)
- existed CNS disease or injuries
- known allergy to propofol, midazolam or alfentanil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flumazenilEEG is observed in both groups to compare the difference between two groups. | Drug | GABA antagonist |
| PlacebosPlacebo is the normal saline, which is given in the controlled group. | Drug | Placebo |
Primary outcome
The characteristic differences in EEG
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flumazenil in people with Moderate Sedation and Colonoscopy, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying-Tzu Li, MD (00886919086631, B94401037@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The characteristic differences in EEG (time frame: Start from the colonoscopy to 30 minutes after the end of colonoscopy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.