跳至主要内容
临床试验/NCT02931786
NCT02931786已完成不适用

Does Magnetic Resonance Imaging Increase Core Body Temperature in Anesthetized Children? Evaluating the Effects of Propofol and Ketofol

Istanbul University0 个研究点目标入组 90 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
Change in core body temperature

研究概览

简要总结

Investigators researched the effect of two different types of drugs on core body temperature during magnetic resonance imaging. The hypothesis is in ketamine group, thermo disregulation is not as distinct as in propofol group, due to its positive effect on thermo regulation

详细描述

Intravenous anesthetics may impair thermoregulation. Absorption of radiofrequency waves by the body surface may result in heating, especially in small children during magnetic resonance imaging (MRI). Investigators applied two different intravenous anesthetics as propofol and ketamine and studied the effect of these drugs on core body temperature.

All patients aged between 6 months-10 years were administered midazolam and atropine. After that 1 mg/ kg of propofol was applied in group I, and 0,1 ml/kg of propofol ketamine mixture ( 10 mg/ml each) was applied in group II. Core body temperatures were taken before and after MRI and compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged between 6 months-10 years,
  • underwent MRI under anesthesia

排除标准

  • History of drug allergy
  • Severe pulmonary and cardiac disease
  • Intracranial hypertension

研究组 & 干预措施

propofol

Active Comparator

body core temperature was measured from tympanic membrane after 1 mg/kg propofol administration, before and after magnetic resonance imaging

干预措施: propofol (Drug)

propofol

Active Comparator

body core temperature was measured from tympanic membrane after 1 mg/kg propofol administration, before and after magnetic resonance imaging

干预措施: Ketamine propofol mixture (Drug)

ketofol

Active Comparator

body core temperature was measured from tympanic membrane after 0,1 ml/kg administration of ketamine propofol mixture of 10 mg/ml both, before and after magnetic resonance imaging

干预措施: propofol (Drug)

ketofol

Active Comparator

body core temperature was measured from tympanic membrane after 0,1 ml/kg administration of ketamine propofol mixture of 10 mg/ml both, before and after magnetic resonance imaging

干预措施: Ketamine propofol mixture (Drug)

结局指标

主要结局

Change in core body temperature

时间窗: during magnetic resonance imaging (MRI) procedure

temperature was taken from tympanic membrane bilaterally before and after MRI. If temperature change was more or les than 0.1 degrees celsius the patient was considered as warmer or cooler.

次要结局

未报告次要终点

研究者

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

Dr Cigdem Akyol Beyoğlu

medical specialist

Istanbul University

相似试验