Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Dose of Fentanyl Used
研究概览
简要总结
The purpose of this study is to examine the effects of different sedation drugs used for the awake fiberoptic intubation procedure. Benzodiazapines and narcotics (such as midazolam and fentanyl) are standard drugs used for sedation during awake fiberoptic intubation. Dexmedetomidine, midazolam, and fentanyl are approved by the Food and Drug Administration (FDA) procedural sedation. These drugs might be given to the patient regardless of their participation in the study.
In addition to midazolam and fentanyl study subjects will also receive either dexmedetomidine or a placebo (a salt solution that contains no drug). It is believed that dexmedetomidine will not slow down breathing as much as the combination of the valium-like drug and narcotic. In our study, we are trying to determine if this is the best drug for sedation during an awake fiberoptic procedure.
详细描述
This is an observational study designed to evaluate effectiveness of two standard of care protocols used for patients with potentially difficult airway during awake fiberoptic intubation.
After obtaining informed consent, patients will be randomized into one of two groups. The first group will receive placebo, midazolam, and fentanyl (titrated to effect) to facilitate the intubation. The second group will receive dexmedetomidine, midazolam, and fentanyl (titrated to effect) to facilitate intubation. Both groups will have a transtracheal injection and/or direct topical application of lidocaine to decrease irritation of the trachea and vocal cords.
As the patients in the study all have potentially difficult airways, the usual precautions will be taken to minimize the risks to the patients. These include the availability of alternative airway devices (including LMAs and Intubating LMA systems). Doses of dexmedetomidine will conform to the recommended dosing schedules of between 0.3 and 0.7 mcg/kg/hour.
All the drug stated above are currently FDA approved and are used according to the standard of care.
Patient medical records will be reviewed to determine the amount of fentanyl that was used to facilitate intubation as well as homodynamic stability during the procedure and oxygen saturation. A brief 5-minute survey will be conducted 24 hours after the surgery to access patient satisfaction with intubation procedure. Intubation conditions stated below will be recorded by the anesthesiologist during the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with potentially difficult airways who require awake fiberoptic intubations will be identified from the OR schedule and the pre-operative clinic workups.
排除标准
- •Anyone who does not meet the inclusion criteria
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine, midazolam, and fentanyl (titrated to effect) to facilitate intubation
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Dose of Fentanyl Used
时间窗: During intubation
mcg
Hemodynamic Lability
时间窗: During intubation
mm Hg
Desaturation
时间窗: During intubation
Measurement using pulse oximetry (percent saturation)
次要结局
- Patient overall experience assessed by VAS satisfaction.(24 hours after the surgery)
研究者
David Glick
Department of Anesthesiology Head
University of Illinois at Chicago