ROLE OF PRE-OPERATIVE DEXMEDETOMIDINE NEBULISATION 1 VS 2µg/kg IN BLUNTING HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND INTUBATION
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- •To find most effective dose of nebulised dexmedetomidine with minimal side effect in blunting haemodynamic response to laryngoscopy and intubation by comparing HR, SBP, DBP and MAP at pre-induction, pre-intubation, after-intubation and upto 10 minutes post intubation.
研究概览
简要总结
Dexmedetomidine, a potent, highly selective alpha-2 adrenergic receptor agonist have been used for blunting haemodynamic response to laryngoscopy and intubation through IV, intranasal and nebulised routes. Nebulised dexmedetomidine 1µg/kg effectively blunts increase in heart rate (HR) but not systolic blood pressure (SBP). Dexmedetomidine nebulisation with 2µg/kg dose may help in blunting both tachycardia and hypertensive response.A prospective, randomized, study will be conducted on 150 ASA I and II patients undergoing surgery under general anaesthesia with endotracheal tube (ETT) insertion, who will be divided into 3 groups of 50 patients each. In groups 0, I and II, patients will be nebulised for 10 minutes with 5 ml of 0.9% NaCl solution containing 0, 1 and 2 µg/kg dexmedetomidine respectively, 10 minutes before induction. Heart rate, Systolic, diastolic and mean arterial pressure (MAP) will be monitored and recorded at regular intervals and the data so collected will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Age more than 18 years •ASA I & II patients undergoing surgery under general anaesthesia •Patient with Mallampati class 1 or 2.
排除标准
- •â€¢Pregnant females •Patient with unstable haemodynamics •Predicted airway difficulty •ASA III & IV patients •Known allergy to dexmedetomidine.
结局指标
主要结局
•To find most effective dose of nebulised dexmedetomidine with minimal side effect in blunting haemodynamic response to laryngoscopy and intubation by comparing HR, SBP, DBP and MAP at pre-induction, pre-intubation, after-intubation and upto 10 minutes post intubation.
时间窗: BASELINE, after 5 mins i.e during nebulisation, after 10 mins i.e post nebulusiation, Pre-induction, Pre-intubation, Post intubation and then after every one min till BP and HR comes normal.
次要结局
- •To compare effect of 1 & 2 μg/kg nebulised dexmedetomidine on reduction of induction dose of propofol.(•To compare incidence and magnitude of complication associated with use of 1 & 2 μg/kg nebulised dexmedetomidine.)