Comparison of nebulised ropivacaine 0.75%, nebulised dexmedetomidine on hemodynamic response on intubation in patients undergoing surgery under general anaesthesia : A comparative double blind placebo controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To compare the hemodynamic response of nebulised ropivacaine 0.75% with nebulised dexmedetomidine and with saline during intubation in patients undergoing surgery under general anesthesia.Â
研究概览
简要总结
Sympathetic stimulation due to laryngoscopy and endotracheal intubation results in hemodynamic fluctuations both at intubation as well as extubation. This unwanted hemodynamic response may have deleterious effects in some patients. Various methods are employed for suppression of hemodynamic pressor response at intubation eg iv opioids, alpha agonists, lignocaine etc but at the expense of systemic effects. We will use long acting local anaesthetic ropivacaine 0.75% and alpha agonist dexmedetomidine through ultrasonic nebulisation for direct local action of the drug in the airway.
Total 180 patients will be enrolled for this randomised double blinded placebo controlled study.
The primary objective of the study will be to compare the hemodynamic response of nebulised ropivacaine 0.75% with nebulised dexmedetomidine and with saline during intubation in patients undergoing surgery under general anesthesia. hemodynamic response at extubation , cough response grading and post operative sore throat will also be observed.
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
- •1.American Society of Anesthesiologists (ASA) physical status I.
- •II 2.Age – 18-60 years
- •Scheduled to undergo elective surgery of duration < 2 hours under general anaesthesiaÂ.
排除标准
- •1.Patient with pre operative sore throat or upper respiratory tract infection 2.Patients with history of allergy to local anesthestics 3.Patents with history of allergy to Dexmedetomidine 4.Patients with history of cardiac, liver or renal disorders.
- •Patient with anticipated difficult airway with anticipated duration of laryngoscopy > 15 seconds
- •patients who refuse to participate.
结局指标
主要结局
To compare the hemodynamic response of nebulised ropivacaine 0.75% with nebulised dexmedetomidine and with saline during intubation in patients undergoing surgery under general anesthesia.Â
时间窗: before and after nebulisation, before intubation, at the time of intubation and 5 minutes after intubation
次要结局
- To compare the hemodynamic parameters at extubation.
- To compare cough response after extubation(0 ,5 and 30 minutes)
- to assess for post operative sore throat(0,2,4,6,12,24 hours)