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临床试验/NCT02935959
NCT02935959已完成1 期

Premedication With Different Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
90
试验地点
1
主要终点
the degree of sedation when the child was first seen in the OR

研究概览

简要总结

Evaluate the efficacy of nebulized dexmedetomidine, nebulized ketamine, and nebulized midazolam a premedication prior to general anesthesia (GA) in oncologic preschool children undergo bone marrow aspirate and biopsy.

详细描述

The preoperative period can be a traumatic time for young children undergoing surgery. Pediatric anesthesiologists strive to minimize distress for children in the operating room (OR) environment and to provide a smooth induction of anesthesia. Preoperative anxiety stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in heart rate (HR), blood pressure, and cardiac excitability. Various drugs have been advocated as premedication to allay anxiety and facilitate the smooth separation of children from parents. The ideal premedicant in children should be readily acceptable and should have a rapid and reliable onset with minimal side effects. Dexmedetomidine is a tasteless, colorless, and odorless drug that acts as a selective α-2 adrenergic agonist with both sedative and analgesic effects via actions in the central nervous system. Ketamine is an N-methyl-d-aspartate receptor antagonist that produces a state of sedation, anesthesia, immobility, analgesia, amnesia, and dissociation from the environment. Midazolam is a water-soluble benzodiazepine known to have a rapid onset and short duration of action, as well as properties of amnesia and anxiolysis. Administered intranasally, midazolam is an effective option for conscious sedation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • physical status I and II, scheduled for bone marrow aspirate and biopsy

排除标准

  • known allergy to the studied drugs,
  • organ dysfunction,
  • cardiac dysrrhythmia and/or congenital heart disease,
  • psychotropic medication use and mental retardation

研究组 & 干预措施

nebulized ketamine

Active Comparator

patients will be premedicated with nebulized ketamine solution (2 mg/kg)

干预措施: nebulized ketamine (Drug)

nebulized dexmedetomidine

Active Comparator

patients will be premedicated with nebulized dexmedetomidine solution (2 μg/kg)

干预措施: nebulized Dexmedetomidine (Drug)

nebulized midazolam

Active Comparator

patients will be premedicated with midazolam (0.2 mg/kg) nebulized solution

干预措施: nebulized midazolam (Drug)

结局指标

主要结局

the degree of sedation when the child was first seen in the OR

时间窗: 30 minutes after sedation

measure the degree of sedation using using a 5 point sedation scale. Sedation level: Agitated =1, alert= 2, calm= 3, drowsy = 4, asleep=5.

次要结局

  • parental separation(30 min after sedation)
  • Emergecy agitation(30 min after induction)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shereen Mamdouh

lecturer of anesthesia,ICU and pain management

Assiut University

研究点 (1)

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