Comparison of two different doses of Dexmedetomidine in attenuation of Sevoflurane associated Emergence Agitation in paediatric patients posted for lower abdominal surgeries A Hospital based Randomised Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare effects of 0.3 mcg/kg and 0.5mcg/kg of dexmedetomidine in attenuation
研究概览
简要总结
its a novel study comparing the effects of two different doses of dexmedetomidine on the emergence agitation with the use of inhalational agent such as sevoflurane in pediatric patients undergoing lower abdominal surgeries performed under general anesthesia with a laryngeal mask airway and caudal anesthesia. it shall provide valuable insight on the usage of the optimal dexmedetomidine dose to avoid or reduce the incidence of sevoflurane associated emergence agitation in pediatric patients.
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
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status I and II.
- •Age between 2 to 10 years.
- •Patients undergoing lower abdominal surgeries Operation time less than or equal to 1 hour.
排除标准
- •risk of aspiration known difficult airway Patients with Upper respiratory tract infections congenital malformations involving respiratory tract History of epilepsy Patients with cardiac, renal or liver diseases Patients with allergy to the study drug cervical spine disease.
结局指标
主要结局
To compare effects of 0.3 mcg/kg and 0.5mcg/kg of dexmedetomidine in attenuation
时间窗: after surgery | 10 mins | 20 mins | 30 mins | 40 mins | 50 mins | 1 hour | every 1 hour until 24 hours
of emergence agitation in paediatric patient maintained on Sevoflurane, undergoing
时间窗: after surgery | 10 mins | 20 mins | 30 mins | 40 mins | 50 mins | 1 hour | every 1 hour until 24 hours
lower abdominal surgeries.
时间窗: after surgery | 10 mins | 20 mins | 30 mins | 40 mins | 50 mins | 1 hour | every 1 hour until 24 hours
次要结局
- Hemodynamic parameter assessment for 24 hours after administration of study drug.(every 1 hour until 24 hours post surgery)
研究者
Dr Tejasvini Kalathuru
JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI