A comparative study between Cis-atracurium and Atracurium for assessment of intubating conditions and hemodynamic stability in pediatric patients undergoing surgery: A randomised double blind study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To compare effectiveness of Cis-atracurium and Atracurium at dose of 0.2mg/kg and 0.5mg/kg respectively with regards to intubating conditions. Intubating conditions will be assessed using Cooper et al scoring system.
研究概览
简要总结
Muscle relaxant is crucial component of general anesthesia which facilitates laryngoscopy and endotracheal intubation, prevents voluntary and reflex movements preventing vocal cord damage. Cis-atracurium and Atracurium are Non depolarising muscle relaxant. Cis-atracurium is 4 times more potent than Atracurium with their ED95 being 0.05mg/kg and 0.23mg/kg respectively. The study is to compare the effectiveness of Cis-atracurium and Atracurium at dose of 4ED95 and 2ED95 which is 0.2mg/kg and 0.5mg/kg respectively with regards to intubating conditions and hemodynamic stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •a Patient’s guardian consent b Age group 3 to 12 years c ASA grade 1 and 2 d Patient posted for surgery requiring general anaesthesia and endotracheal intubation e Expected duration of surgery should be less than 90 minutes.
排除标准
- •a ASA grade 3 and 4 b Anticipated difficult airway c Comorbid conditions d Upper and lower respiratory tract infection e Known history of allergy to any of the study drug.
结局指标
主要结局
To compare effectiveness of Cis-atracurium and Atracurium at dose of 0.2mg/kg and 0.5mg/kg respectively with regards to intubating conditions. Intubating conditions will be assessed using Cooper et al scoring system.
时间窗: 3minutes after injection of muscle relaxant, laryngoscopy will be performed. | At the time of laryngoscopy, and just after intubation, intubating conditions will be assessed using Cooper et al scoring system.
次要结局
- To assess hemodynamic stability. Systolic Blood pressure, Diastolic blood pressure, Mean Arterial Pressure, Heart rate will be monitored at given time points.(1. baseline parameters before induction)
研究者
Abhishek Hansdak
Rajendra Institute of Medical Sciences