TO EVALUATE THE ROLE OF MIDAZOLAM PREMEDICATION IN FACILITATING FACE MASK VENTILATION DURING INDUCTION OF GENERAL ANAESTHESIA
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Difficulty of face mask ventilation assessed by Warters grading scale after study drug administration
研究概览
简要总结
This Study is being conducted to evaluate the effect of Midazolam administration before induction on the ease of face mask ventilation in patients with normal airway. Primary outcome assessed would be difficulty of face mask ventilation assessed by Warters grading scale after study drug administration. Other outcomes assessed would be Incidence of difficult mask ventilation (Warters scale >2) after study drug administration, Anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.Dose of propofol required for induction of anaesthesia,
Bispectral index (BIS) values measured during mask ventilation after study drug administration, Correlation between BIS values and Warters scale during mask ventilation after study drug administration and adverse effects like incidence of hypotension or bradycardia during study period.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL GRADE I, II.
排除标准
- •Patients requiring rapid sequence intubation Patients requiring awake intubation.
- •Patients with risk of pulmonary aspiration Patients having allergy to the midazolam Patients having current cervical spine disease or history of cervical spine surgery Patients with BMI ≥ 30kg/m2 Patients with history of sleep apnea Patients with craniofacial anomaly Patients having any contraindications to sedative premedication.
结局指标
主要结局
Difficulty of face mask ventilation assessed by Warters grading scale after study drug administration
时间窗: Difficulty of face mask ventilation assessed by warters grading scale 1 min after giving muscle relaxant vecuronium.
次要结局
- Incidence of difficult mask ventilation (Warters scale ≥2) after study drug administration.(The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.)
- Incidence of difficult mask ventilation after study drug administration.(The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.)