Comparison of incidence of emergence delirium in paediatric patients undergoing general anaesthesia using Propofol and Dexmedetomidine: A randomized comparative open label trial

Dr S N Medical College Jodhpur1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2021年5月2日最近更新: 2021年2月2日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 80
试验地点: 1
主要终点: To compare the incidence of emergence delirium in subjects receiving propofol or dexmedetomidine at the end of surgery with sevoflurane anaesthesia during a period of six months.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

By assessment andcomparison of propofol and dexmedetomidine in paediatric patients undergoingsevoflurane anaesthesia, we wish to see the difference in the incidence ofemergence delirium in these patients.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 2.00 Year(s) 至 6.00 Year(s)（—）
性别: All

入选标准

•Patients aged 2 to 6 years of either gender of ASA PS I and II undergoing surgery under general anaesthesia with sevoflurane lasting less than 120min.

排除标准

•1.Parentsâ€™ refusal.
•2.Patients posted for elective surgery under regional anaesthesia.
•3.ASA III and IV 4.Patients with active URI.
•5.Patient with history of previous psychiatric illness.
•6.Patients with a history of developmental delay 7.Patients having congenital airway problems, cardiac disorders or syndromic babies 8.Patients having psychological disorders, epilepsy and allergy to the study medications 9.Surgeries lasting for more than 120 min 10.Surgeries requiring endotracheal tube insertion for securing the airway.

结局指标

主要结局

To compare the incidence of emergence delirium in subjects receiving propofol or dexmedetomidine at the end of surgery with sevoflurane anaesthesia during a period of six months.

时间窗: 30 min

次要结局

To compare the hemodynamic parameters (HR, SBP, DBP, MAP, RR, SpO2, and ECG), sedation level, recovery time and post-operative pain between groups receiving propofol and dexmedetomidine.(30 min)

研究者

发起方

Dr S N Medical College Jodhpur

申办方类型

Government medical college

研究点 (1)

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