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临床试验/CTRI/2024/11/076789
CTRI/2024/11/076789尚未招募4 期

Comparison of ketamine vs dexmedetomidine given prior to extubation for prevention of emergence agitation in pediatric patients undergoing tonsillectomy- A double blinded randomized control trial.

Heritage Institute of Medical SciencesNH BypassBhadwarvaranasiUttar PradeshIndia1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年11月24日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
To Compare the efficacy of ketamine (0.5mg/kg) vs dexmedetomidine (0.3mcg/kg) for prevention of emergence agitation using PAED scale

研究概览

简要总结

•Emergence agitation (EA) is a phenomenon that includes restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anesthesia. The incidence of Emergence agitation varies widely from approximately 0.25% to 90.5%, according to age, assessment tool used, definitions, anaesthesia techniques, type of surgery, and time at which Emergence agitation is assessed during recovery.

•  The incidence of emergence agitation after sevoflurane anaesthesia estimated at 80%. Emergence agitation occurs most frequently in preschool children during the early stage of emergence from anaesthesia.

•  Emergence agitation is commonly self-limited and happens within first 30 min of stay in a postanesthesia care unit (PACU) and also can lead to disconnection of monitoring devices or intravenous catheter, physical damage, falling, increase risk of bleeding.

•Ketamine is a N-methyl-D-aspartate (NMDA) receptor antagonist with a strong analgesic effect if given in less than anesthesia-induction dose . At small doses (<1 mg/kg), it does not cause respiratory depression and has little effect on the heart rate and blood pressure .

  Dexmedetomidine is a highly selective α2 adrenergic receptor agonist which can produce pharmacological effects of anxiolysis, sedation, and analgesia without overt respiratory and circulatory inhibition in a routine dose. Dexmedetomidine can improve the cognitive function in children during recovery from general anesthesia and contributes to dose-dependent inhibition of emergence agitation after medical procedures .

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
6.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children aged ranged between 6 and 18 years belonging to ASA grade I scheduled for elective tonsillectomy.

排除标准

  • Children with Congenital anomalies, developmental problems, Inborn errors of metabolism, cerebral palsy, down syndrome.
  • Obese children with a risk of airway obstruction.
  • Patients with previous history of agitation after sevoflurane anesthesia and patients with respiratory distress of any cause.
  • Children with known allergy to any of the medications used.
  • Non willing patients.
  • Prolonged or any other complication during surgery.

结局指标

主要结局

To Compare the efficacy of ketamine (0.5mg/kg) vs dexmedetomidine (0.3mcg/kg) for prevention of emergence agitation using PAED scale

时间窗: Immediately after emergence and at 10-minute,20-minute and 30-minute.

次要结局

  • To assess pain intensity using FLACC scale(After extubation ,10 minute,20 minute & 30 minute).

研究者

发起方
Heritage Institute of Medical SciencesNH BypassBhadwarvaranasiUttar PradeshIndia
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sauraya Pratap Singh

Heritage Institute of Medical Sciences ,Varanasi

研究点 (1)

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