跳至主要内容
临床试验/CTRI/2020/02/023660
CTRI/2020/02/023660尚未招募不适用

A prospective, observational study to assess the incidence of Emergence Delirium inPediatric patients undergoing elective surgical procedures under General Anesthesia.

INSTITUTIONAL REVIEW BOARD1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2020年2月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
190
试验地点
1
主要终点
To determine the incidence of emergence delirium among pediatric patients undergoing general anesthesia for elective surgical procedures

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, moaning or incoherent. The average estimated incidence of emergence delirium is between 18-30%. The risk factors involvedin emergence delirium include anaesthetic factors such as the type of  the agent used, presence of post operativepain and time taken for emergence from anaesthesia. Patient factors such as their age, period of preoperative fasting,presence of anxiety and parental anxiety also contribute to emergence deliriumalong with the type of surgical procedure being performed. Although the term emergence agitation has been limited to the post operative period, study done by Levy et al has shown that these children exhibit behavioural changes well beyond the recovery period  from general anaesthesia. As stated above in the definition of emergence delirium, includes any such behaviour as thrashing, uncooperative behaviour which can put the patient and healthcare provider at a risk of injury. Any injury to the patient at the surgical site doubles the duration of hospital stay and cost involved in their treatment.

The studies done previously have shown that inhalational agents such as halothane, isoflurane, desflurane  and sevoflurane have contributed to emergence delirium. However sevoflurane has been found to been the greatest contributor of emergence delirium in children . Hence we undertake this study to   further decipher the incidence of emergence delirium in our population using sevoflurane followed by isoflurane.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Pediatric patients (age 2years-18years) Elective surgical procedures ASA 1 & 2.

排除标准

  • Less than 2 years ASA 3, 4 Obese (BMI more than 30) Emergency surgeries Developmental delay On psychotropic medicines.

结局指标

主要结局

To determine the incidence of emergence delirium among pediatric patients undergoing general anesthesia for elective surgical procedures

时间窗: Immediately at the end of surgery and 15 minutes thereafter up to 45 minutes in post anaesthesia care unit.

次要结局

  • To identify the possible risk factors associated with emergence delirium in our population such as age, duration of pre operative fasting, pre medication(administered, parental presence, duration of surgery and post operative pain scores.)

研究者

申办方类型
Private medical college

研究点 (1)

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