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临床试验/NCT02062333
NCT02062333已完成4 期

The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
47
试验地点
1
主要终点
distortion product auto acoustic emission

研究概览

简要总结

The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on Stapes Reflex and Distortion Product Auto Acoustic Emission.

详细描述

This study was aimed at evaluating the effects of dexmedetomidine and esmolol on stapes reflex and distortion product auto acoustic emission. the stapes reflex and auto acoustic emission are of considerable diagnostic significances in otolaryngology this are objective methods for the assessment of auditory function.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 age
  • American Society of Anaesthesiologists physical status classification (ASA)1-2
  • tympanoplasty surgery
  • patients with normal stapes reflexes

排除标准

  • hypertension
  • drug allergy
  • cardiac problems
  • pregnancy

研究组 & 干预措施

dexmedetomidine

Active Comparator

0,4-0,8 µg./kg./h dexmedetomidine

干预措施: Dexmedetomidine (Drug)

esmolol

Active Comparator

100- 300 µg./kg./min esmolol

干预措施: esmolol (Drug)

结局指标

主要结局

distortion product auto acoustic emission

时间窗: postoperative 1 day

distortion product measurements will be performed in 1001, 1501, 2002, 3003, 4004, 6006, 7996 Hz frequencies and change from baseline in distortion product measurements at postoperative 1 day

次要结局

  • stapes reflex(postoperative 1 day)

研究者

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

Recep Aksu

associate professor

TC Erciyes University

研究点 (1)

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