- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00695630
Flumazenil Reversal of Oral Triazolam
June 11, 2008 updated by: University of Washington
Flumazenil Rescue Strategy
An increase in the utilization of anesthesia and sedation medications by non-anesthesiologists, including dentists, has grown dramatically.
This has been prompted, in part, by the need for pharmacological tools to address high levels of fear and anxiety about dental care among the US population and the evidence of oral health disparities among those who are fearful .
Given the prevalence of dental fear in the general population and in the various populations with the greatest burden of oral diseases, effective sedation techniques are needed that are safe and effective in the hands of general dentists that make up the "front line" in the efforts to reduce oral health disparities.
This study is to determine whether, when compared to a saline placebo, a single intraoral submucosal administration of the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual dosing of triazolam (3 doses of 0.25 mg over 90 minutes).
Study Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- Dental Fears Research Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA I
Exclusion Criteria:
- Use of benzodiazepines, anxiolytics or any other medications that would interact with either triazolam's or flumazenil's metabolism or clinical effect (including herbals) within four weeks of the study
- Body mass index (BMI) no less than 15 kg/m2 and no greater than 30 kg/m2
- Pregnancy or not currently using pharmacologic methods of birth control
- Allergy or sensitivity to benzodiazepines
- History of a seizure disorder; AND
- Chronic tobacco use.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Flumazenil 2mL
|
2 mL, 0.2 mg SM
|
Placebo Comparator: 2
Saline, 2mL SM
|
2 mL sterile saline SM
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Observer Assessment of Alertness/Sedation
Time Frame: 360 minutes
|
360 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BIS
Time Frame: 360 minutes
|
360 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter M Milgrom, DDS, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
June 9, 2008
First Submitted That Met QC Criteria
June 11, 2008
First Posted (Estimate)
June 12, 2008
Study Record Updates
Last Update Posted (Estimate)
June 12, 2008
Last Update Submitted That Met QC Criteria
June 11, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30779
- U54DE014254 (U.S. NIH Grant/Contract)
- T32007132
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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