An interventional randomized comparative study to evaluate the effect of 5% EMLA cream vs lubricating gel on postoperative sore throat in adults following endotracheal intubation under general anaesthesia in Department of Anaesthesia SMS Medical college, Jaipur
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2 severity of POST
研究概览
简要总结
In this randomized, placebo-controlled study, adultpatients of 18 to 50 years old, in American Society of Anesthesiologists (ASA) physicalstatus I and II, and of either sex will be scheduled to receive 5% EMLA cream (interventionarm) or lubricant gel (placebo-controlled arm) applied over the ETT cuff.
A postoperative sorethroat will be graded as none (0), mild (1), moderate (2), or severe(3). Ascore of ≥2 will be considered as significant POST. Theincidence of POST at the sixth at 0, second, and 24 hours will be recorded, andthe incidence of significant POST (score ≥2) will alsobe noted. The incidence and severity of postoperative cough and hoarseness ofvoice will be recorded simultaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant 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
- •1.Patients scheduled for elective surgeries 2.Expected duration of surgery around 2 to 3 hours under general endotracheal anaesthesia 3.Patients belonging to American Society Of Anaesthesiologists (ASA) grade I, II.
排除标准
- •1.Patients allergic to local anaesthetics 2.>2 intubation attempts, assisted nasogastric tube insertion, difficult airway 3.Patients with head and neck surgery involving airway 4.Patients with preoperative sore throat 5.Expected prolonged surgical duration (>3 hours) 6.Postoperative mechanical ventilation 7.Surgeries in prone position.
结局指标
主要结局
2 severity of POST
时间窗: immediately after the surgery | 2 hours post operatively | 6 hours post operatively | 12 hours post operatively | 24 hours post operatively
4 Incidence and severity of post-operative hoarseness of voice
时间窗: immediately after the surgery | 2 hours post operatively | 6 hours post operatively | 12 hours post operatively | 24 hours post operatively
1 incidence of postoperative sore throat(POST)
时间窗: immediately after the surgery | 2 hours post operatively | 6 hours post operatively | 12 hours post operatively | 24 hours post operatively
3 incidence and severity of post-operative cough
时间窗: immediately after the surgery | 2 hours post operatively | 6 hours post operatively | 12 hours post operatively | 24 hours post operatively
次要结局
- N/A(N/A)