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Completed

NCT Number: NCT00695630

Flumazenil Reversal of Oral Triazolam

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).

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dental Fears Research Clinic

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flumazenil

Drug

2 mL, 0.2 mg SM

Placebo

Drug

2 mL sterile saline SM

Primary outcomes

  1. Observer Assessment of Alertness/Sedation

    Time frame: 360 minutes

Secondary outcomes

  1. BIS

    Time frame: 360 minutes

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Flumazenil Rescue Strategy

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 12, 2008
Registry last updated
Jun 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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