Pre-operative Dexmedetomidine and Dexamethasone nebulization in attenuating post-operative sore throat due to endotracheal intubation: A comparative clinical studyâ€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence and severity of post operative sore throat, hoarseness of voice and cough
研究概览
简要总结
The study drug (dexamethasone 0.1mg/kg or dexmedetomidine 1 mcg/kg) will be delivered using a nebulization mask for 15 mins atoxygen source at 8L/min 10 min prior to induction. Post
nebulization vitalswill be recorded .GA will be induced with standard Anaesthesiaprotocol. Injection xylocard 1.5 mg/kg will be given 90 seconds prior to intubation.Intra-operative hemodynamic
monitoring will be done at 0 (post intubation),2,4,6,8,10 mins after intubation, thereafter every 5 mins intra operative period.Smooth extubation followed by monitoring every 15 mins in the PACU.
Assessment for the incidence and severity of sore throat, hoarseness ofvoice and cough will be carried out using a 4-point scale (0-3) at 0, 2, 4, 6,12, 24 hrs post extubation. IV Diclofenac 75 mg
will be given as rescue analgesic for severe sorethroat. Sedation will be monitored according to Ramsay Sedation score.
Any side effects such as dry mouth, post-operative nausea and vomiting(PONV), sedation, respiratory depression and hemodynamic instability will bemonitored and be treated accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I and II Age-18-70, both males and females Patients posted for elective surgeries under GA with endotracheal intubation, lasting < 2hrs duration.
排除标准
- •ASA III, IV Patients Patients with a history of upper respiratory tract infection, Asthma, sore throat.
- •Anticipated difficult airway with Mallam Pati grade >2 Weight >80kgs, smokers.
- •Surgeries requiring nasogastric tube insertion patients undergoing head and neck surgeries.
- •Patients undergoing surgeries in prone position.
- •pregnant and lactating women.
结局指标
主要结局
Incidence and severity of post operative sore throat, hoarseness of voice and cough
时间窗: assessed in the first 24 hours post operatively
次要结局
- Hemodynamic changes and level of sedation(assessed in the first 24 hours post operative period)