跳至主要内容
临床试验/CTRI/2019/02/017671
CTRI/2019/02/017671进行中(未招募)Phase 3 4

Comparison of Atomised vs Nebulised Dexmedetomidine for premedication in children upto 8 years undergoing cataract surgery

Ankur Luthra1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2019年2月20日最近更新:

试验速览

阶段
Phase 3 4
状态
进行中(未招募)
发起方
Ankur Luthra
入组人数
170
试验地点
1
主要终点
Comparison of effectiveness of atomised vs nebulised dexmedetomidine as pre-medication in children undergoing cataract surgery in terms of parental separation score Emotional State Scale-4.

研究概览

简要总结

The preoperative period can be very traumatic for children undergoing surgery. Paediatric anaesthesiologists strive to minimise the distress for children in the operating room to provide smooth induction of anaesthesia. The ideal pre-medicant should be readily acceptable and should have a rapid and reliable onset with minimal side-effects. Dexmedetomidine is a newer alpha-2 agonist that has been used in paediatric patients for procedural sedation and premedication. Intra-nasal administration of premedicants in children is relatively easy and reduces the discomfort associated with intramuscular or intravenous injection. The absolute bioavailability is approximately 82 % following intranasal administration. The time to onset is 15-30 minutes with sedation observed upto 1-2 hours. The atomised form is a relatively safer and newer form of administration, readily acceptable by children. We wish to compare this form with the nebulised form of administration and asses the sedation score in the form of parental separation in the children upto 8 years of age undergoing cataract surgery.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
8.00 Month(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • All ASA I and II children aged 1 to 8 years scheduled for cataract surgery under general anaesthesia.

排除标准

  • Children with cardiac anomalies, upper respiratory tract infection, liver disease, seizures or an acute medical condition, increased intracranial pressure, or a history of dexmedetomidine allergy will be excluded.

结局指标

主要结局

Comparison of effectiveness of atomised vs nebulised dexmedetomidine as pre-medication in children undergoing cataract surgery in terms of parental separation score Emotional State Scale-4.

时间窗: 30 min after intervention

次要结局

  • To Compare(1. Mean time of onset of adequate sedation score)

研究者

发起方
Ankur Luthra
申办方类型
Other [self]

研究点 (1)

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