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临床试验/CTRI/2024/10/075390
CTRI/2024/10/075390尚未招募不适用

Comparing two doses of dexmedetomidine infusion on emergence agitation using desflurane in paediatric surgeries under general anesthesia

Dr Vaishali Waindeskar1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年3月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
The expected Outcome of the proposed study will be to compare the effectiveness of 2 doses dexmedetomidine will decrease emergence agitation in paediatric patients undergoing elective surgeries.

研究概览

简要总结

Emergence agitation (EA) has been defined as a dissociated state of consciousness in which the child is inconsolable, irritable, uncooperative, typically thrashing, crying and  moaning . EA may cause physical harms to patient such as bleeding from site of surgery, psychological trauma, and delayed discharge from postanaesthetic care unit .Children display a variety of behaviour during anaesthetic recovery. Emergence agitation in children is a common problem with sevoflurane anaesthesia which include phenomenon such as crying, excitation, agitation, delirium and behavioural disturbances during early emergence from general anaesthesia . This phenomenon must be prevented by providing smooth emergence to paediatric patients.Postoperative emergence agitation is a common complication in paediatric surgery patients, which increases the risk of developing postoperative airway obstruction and respiratory depression.

Dexmedetomidine is highly specific α2 agonist and  has an analgesic-sparing effect and reduces emergence agitation Dexmedetomidine, , has been shown to prevent emergence delirium and agitation. Administered intravenously, dexmedetomidine is indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in intensive care settings, and for the sedation of non-intubated patients prior to or during surgery and other procedures.

Recently, dexmedetomidine is known to decrease EA in paediatric and day-care surgery following sevoflurane. However, dexmedetomidine IV after anesthetic induction significantly decreases the occurrence of emergence agitation in children undergoing sevoflurane anesthesia.  but its role in preventing post desflurane Emergence Agitation EA has not been elucidated in some studies .

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

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

入选标准

  • Age 2-8 years either gender ASA 1 & 2.

排除标准

  • Patient parent refusing informed consent Patient parent who speaks language other than Hindi or English Emergency surgery Any treatment that affects psychological status Patient not extubated after surgery.

结局指标

主要结局

The expected Outcome of the proposed study will be to compare the effectiveness of 2 doses dexmedetomidine will decrease emergence agitation in paediatric patients undergoing elective surgeries.

时间窗: 2HRS POSTOPERATIVELY

To evaluate effect of dexmedetomidine on MAP , HR , BP , at defined time points.

时间窗: 2HRS POSTOPERATIVELY

次要结局

  • ii)To compare heart rate (HR), blood pressure(BP), oxygen saturation, end-tidal carbon dioxide, and respiratory rate (RR) at regular intervals and evaluated preoperative anxiety, state of agitation, using the validated and widely used Pead’s scale(2 HRS POST OPERATIVELY)

研究者

发起方
Dr Vaishali Waindeskar
申办方类型
Other [guide (hod)]

研究点 (1)

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