Comparison of dexmedetomidine alone with dexmedetomidine and fentanyl during awake fibre-optic intubation in patients with difficulty in intubation: A Randomised Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 3. Coughing
研究概览
简要总结
Awake fiber-optic intubation is a gold standard of management of predicted difficult airway. Sedation is frequently used to make the process more tolerable to the patient. It is not always easy to strike a balance between patient comfort and a good intubating condition on one hand and maintaining ventilation and a patent airway on the other. This study is designed to assess the level of sedation and hemodynamic changes with different doses of pre-operative dexmedatomidine infusion at 1mcg/kg alone Vs. 0.5mcg/kg dexmedetomidine with 1 mcg/kg fentanyl infusion among the study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I and II
- •Patients with difficult intubation.
排除标准
- •Refusal of patient to participate in the study
- •ASA grade II/ III
- •Any allergy to dexmedetomidine
- •Patients on any of the following: a.
- •Higher degree of A-V block b.
- •Treatment with ACE Inhibitors, digoxin or beta adrenergic antagonist c.
- •Treatment with alpha-2 agonist d.
- •Long term use of benzodiazepine or TCA e.
- •Treat with anticoagulants
- •Bleeding disorders
- •Pregnant and nursing women
- •Morbid obesity
- •Lack of cooperative and effective communication
- •Patients requiring post operative ventilatory support.
结局指标
主要结局
3. Coughing
时间窗: At the time of attempting awake fibre optic intubation
4. Limb movement
时间窗: At the time of attempting awake fibre optic intubation
5. Fiberoptic intubation comfort score indicating patient tolerance; It was evaluated using a 5 point score
时间窗: At the time of attempting awake fibre optic intubation
6. Ramsay sedation score: using 6 points
时间窗: At the time of attempting awake fibre optic intubation
7. Patient satisfaction score
时间窗: At the time of attempting awake fibre optic intubation
1. Airway obstruction score was evaluated using a 3 degree scale
时间窗: At the time of attempting awake fibre optic intubation
2. Intubation score was evaluated according to Vocal cord movement
时间窗: At the time of attempting awake fibre optic intubation
次要结局
- 1. Haemodynamic variables:(a. heart rate)