Flumazenil Rescue Strategy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Observer Assessment of Alertness/Sedation
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
1
Flumazenil 2mL
干预措施: Flumazenil (Drug)
2
Saline, 2mL SM
干预措施: Placebo (Drug)
结局指标
主要结局
Observer Assessment of Alertness/Sedation
时间窗: 360 minutes
次要结局
- BIS(360 minutes)
