Fospropofol for Sedation During Elective Awake Intubation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rescue intubation needed
研究概览
简要总结
Patients scheduled for awake fiberoptic intubation (AFI) because of potential difficult airway will be consented prior to intubation ASA Physical Status classification and history of difficult intubation will be recorded at screening. The investigators will also record the results of airway examination including Mallampati classification, thyromental distance, mouth opening, neck circumference, neck range of motion, presence or absence of beard and overbite, history of neck radiation, and mandibular protrusion test Informed consent will be obtained prior to the procedure from those patients who meet the inclusion and exclusion criteria.
Standard hemodynamic monitoring will be used in all patients including EKG, blood pressure, heart rate, respiratory rate and oxygen saturation. Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale will be used to assess the level of alertness/sedation. Two consecutive MOAA/S scores of 4 will be considered as the desired effect of moderate sedation.
For AFI procedure, IV will be started and oxygen will be administered. 4 L of oxygen will be delivered through nasal canula until the completion of the AFI procedure. Patient head will be positioned in the sniffing position, Topical anesthesia would be achieved using the topical administration of 4 percent lidocaine using atomized and MaDgic nebulizer, and 2% xylocaine Jel applied to the surface of Williams airway in a total dose of lidocaine not exceeding 10 mg/kg. Patients will be randomized to one of the four fospropofol treatment arms: 2, 3.5, 5, or 6.5 mg/kg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: between 18-64 years of age
- •ASA physical status 1-3 ( Except patients with severe cardiac and/or pulmonary disease
- •Weight 60-90 Kg
- •Elective surgery requiring awake FOI
- •Male or female, female patients should not be pregnant (documented by morning of surgery urine pregnancy test result as per routine hospital policy) or lactating
排除标准
- •Previous exposure to any experimental drug within 30 days prior to study drug administration
- •Raised intracranial pressure
- •Patients for whom propofol is contraindicated
- •Allergy to midazolam and/or fentanyl
研究组 & 干预措施
fospropofol 6.5 mg/kg.
Patient randomized to receive fospropofol for awake intubation at 6.5 mg/kg.
干预措施: fospropofol (Drug)
fospropofol 5 mg/kg.
Patient randomized to receive fospropofol for awake intubation at 5 mg/kg.
干预措施: fospropofol (Drug)
fospropofol 3.5 mg/kg.
Patient randomized to receive fospropofol for awake intubation at 3 mg/kg.
干预措施: fospropofol (Drug)
fospropofol 2 mg/kg.
Patient randomized to receive fospropofol for awake intubation at 2 mg/kg.
干预措施: fospropofol (Drug)
结局指标
主要结局
Rescue intubation needed
时间窗: every 4 minutes during procedure, day 1
Requiring rescue midazolam and or fentanyl to facilitate intubation
Hypotension
时间窗: every 2 minutes, during procedure, day 1
Development of hypotension ( defined as blood pressure drop of more than \>30 % of base line) and/or hypoxemia ( SaO2 \< 90% or a drop of \>5% of baseline , whichever is lower)
次要结局
- Time to intubate(seconds, during procedure, day 1)
- Failed intubation(seconds, day 1)
- ease of intubation(seconds, after intubation, day 1)
- hypertension(every 2 minutes, during procedure day 1)
- Total dose of midazolam and fentanyl used(end of procedure, day 1)
- Patient recall and satisfaction(end of procedure,day 1)
- unresponsiveness(seconds, during procedure, day 1)