Ketamine Versus Lidocaine Nebulization for Awake Nasal Fiberoptic Intubation: a Prospective, Randomized Double-blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dose of supplemental lidocaine
研究概览
简要总结
This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.
详细描述
Difficult airway is one of the major challenges facing anesthesiologists. This challenge is compounded when the patient is treated while awake. The additional burden is to complete this procedure comfortably thus ensuring patient cooperation which is a vital part of successful performance. Several methods have been tried in literature to facilitate awake intubation by fiberoptic bronchoscope (FOB)
This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I and II of both sexes with body weight from 60-90 kg, and planned for elective awake nasal fiberoptic intubation due to expected difficulty in airway management (e.g. limited mouth opening, trismus, mandibular/ maxillary swellings or tumors, ludwig's angina, or other indications).
排除标准
- •body weight < 60 kg or > 90 kg
- •uncooperative, with mental or psychological problems
- •known allergy to any of the study drugs
- •pregnancy
- •hypertension
- •cardiac disease
- •liver or renal impairment
- •epilepsy,
- •asthmatic,
- •previous bad experience of awake intubation,
- •emergency operations or
- •coagulation abnormalities
研究组 & 干预措施
Ketamine group
Nebulization with ketamine
干预措施: Ketamine (Drug)
Lidocaine group
Nebulization with with lidocaine
干预措施: Lidocaine (Drug)
结局指标
主要结局
Dose of supplemental lidocaine
时间窗: Intraoperative
Dose of supplemental lidocaine during awake fiberoptic procedure
次要结局
- Incidence of adverse events(Intraoperative)
- Patient tolerability score(Intraoperative)
- Patient satisfaction score(first 24 hours)
研究者
Ayman Ahmad Alsayed Abdellatif
Assistant Professor
Ain Shams University