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临床试验/NCT02368782
NCT02368782已完成不适用

Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children With Normal Hearing Tests Undergoing Adenoidectomy and Tonsillectomy

Istanbul University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
DPOAE and TEOAE

研究概览

简要总结

Otoacoustic emissions (OAEs) are non-invasive, easy to apply and objective test methods which are widely used to determine the presence of hearing in audiology clinics. Under some circumstances and children, the study should be applied under general anaesthesia. The aim of this study was to find out the influence of propofol (P) and ketamine (K) on OAE measurements. .

Methods: Thirty- healthy children who will underwent adenoidectomy and tonsillectomy will be included in this study after Institutional ethics committee approval and informed consent of parents. Children will be evaluated one day before surgery by tympanometry. Psychologically prepared children will be admitted to the operating room. Following EMLA (Eutectic Mixture of Local Anesthetics ) cream application IV line will be inserted. ECG and non-invasive blood pressure will be monitored. Transient evoked otoacoustic emissions (TEOAEs) and distortion product otoacoustic emissions (DPOAEs) will measured in both ears of each patient (n=20 ears) prior to P or K administration( Pre-P and Pre-K). Propofol will be given 2mg/kg or ketamine 2mg/kg intravenously and 40% O2 in air will be given by mask ventilation. Five minutes later TEOAE and DPOAE measurements will be repeated (Post-P and Post-K). After this measurement the routine general anaesthesia and surgical protocol will be commenced. Heart rate, blood pressures TEOAE and DPOAE measurements will be compared at pre and post stages by paired Student's t- test.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children ages 4-15 years ASA ( American Society of Anesthesiologists) I-II Tonsillectomy and/or adenoidectomy Normal ear hearing tests

排除标准

  • Abnormal hearing tests Abnormal laboratory (Electrolyte imbalance, anemia, polycythemia, thrombocytopenia, leucopenia , leucocytosis) Congenital abnormalities and previous systemic diseases Hypo or hyperthermia Ear operations Long term fasting, dehydration or over hydration Upper respiratory disease, acute or chronic otitis,

结局指标

主要结局

DPOAE and TEOAE

时间窗: Pre and post propofol or ketamine administration

Before and after the administration of propofol or ketamine measurements of DPOAE and TEOAE will be performed

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

Prof. Dr. A. Pervin SUTAS BOZKURT

Prof. Dr.

Istanbul University

研究点 (1)

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