efficacy of supraglottic and subglottic instillation of dexamethasone or dexmedetomidine for the incidence and severity of postoperative sore throat after general anaesthesia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- To compare the efficacy of supraglottic and subglottic Instillation of dexamethasone verses dexmedetomidine in decreasing the incidence and severity of post operative sore throat (POST) after general anaesthesia.
研究概览
简要总结
After enrolment in the study with the consent of thepatients, they will be assessed preoperatively. All patients will be NPO 8 hrsbefore operation. All thesubjects will be divided into two groups, Group A and Group B in the ratio of1:1 according to random number table. All Patients and anaesthetists will beblinded to group assignments. On bringing the patient to operating room, baseline recording of ECG, SBP, DBP, MBP, HR, RR will be measured using themonitor. The vein channel is to be established during a 18G indwelling needle.A simple face mask will be used for Oxygen for 3 minutes. Then anaesthesia willbe induced through intravenous injection of 2ug/kg Fentanyl, 2mg/kg Propofoland 0.5mg/kg Atracurium/injVecuronium(0.1mg/kg). Afterthree minutes of IPPV, intubation will be performed bydirect laryngoscopy using appropriate size endotracheal tube. A single use highvolume low pressure cuffed ETtube (Tuoren) containing supra & subglotticport for drug instillation will be used for intubation which will be fixed andinflated by 3-5ml of air.After securing ETtube a total volume of 5ml drug (8mgdexamethasone diluted in 3ml normal saline or 100mcg dexmeditomidine diluted in3ml normal sline) will be given in supra & subglottic area through supra & subglottic port of ET tube(Tuoren).
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 65.00 Year(s)(—)
- 性别
- All
入选标准
- •VALID CONSENT , ASA 1 AND 2 , MALLAMPATTI CLASS 1 & 2 , POSTED FOR SURGERY UNDER GENERAL ANAESTHESIA.
排除标准
- •REFUSAL , ASA 3 OR MORE , AGE LESS THAN 18 YRS AND MORE THAN 65 YRS , HISTORY OF UPPER RESPIRATORY TRACT SENSITIVITY AND SORE THROAT , PREGNANCY , MORBID OBESITY , ICU TRANSFERRED PATIENTS WITH E.T TUBE IN SITU.
结局指标
主要结局
To compare the efficacy of supraglottic and subglottic Instillation of dexamethasone verses dexmedetomidine in decreasing the incidence and severity of post operative sore throat (POST) after general anaesthesia.
时间窗: 0, 2 hr, 4 hr, 6 hr, 12 hr, 24 hr
次要结局
- To assess the post operative hemodynamic stability, Pain on deglutition, Hoarseness, Cough or any other adverse effects.(0 , 2 hr , 4 hr , 6 hr , 12 hr , 24 hr)
