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临床试验/NCT02830815
NCT02830815已完成不适用

Comparative Effects of Two Anesthetic Techniques on Auditory Brain Response in Children

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年6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
80
试验地点
1
主要终点
Qualitative interpretability of ABR testing in the same patient undergoing two anesthetic techniques

研究概览

简要总结

This will be a prospective, blinded, cross-over study to compare the effects of two anesthetic techniques on the interpretability of auditory brainstem response testing in children.

详细描述

The proposed study will be a single-center, prospective, crossover-controlled study of the two anesthetic techniques (propofol and sevoflurane). The investigators plan to enroll 80 patients who receive general anesthesia at Cincinnati Children's Hospital Medical Center Department of Radiology for ABR testing. A sample size recalculation will be performed during the study to determine the exact number of subjects necessary for sufficient power. As per standard anesthesia practice for this test in radiology department, all subjects will serve as their own control, receiving both anesthetic techniques within the same ABR testing session. The audiologist will employ broadband click stimulus testing after induction with Sevoflurane, after which the patient will be switched over to a propofol infusion and the sevoflurane stopped. After the completion of the remainder of the ABR (tone-burst testing), the audiologist will repeat the broadband click testing (now while under propofol anesthesia), and the results will be recorded. At this point, results will be de-identified, with the exception of which ear was tested and the intensity level, and these results will be reviewed by a panel of 5 audiologists. These audiologists will be blinded to the anesthetic technique and patient information. They will provide a judgment at each intensity level, for each ear whether or not a response is present (in a Yes/No format). A study coordinator blinded to the anesthetic technique will record the outcome data. The anesthesia providers and nursing team will not be blinded.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

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

入选标准

  • 0 - 18 years old
  • ASA status I, II, or III
  • Scheduled for ABR with general anesthesia

排除标准

  • Contraindication to sevoflurane or propofol

结局指标

主要结局

Qualitative interpretability of ABR testing in the same patient undergoing two anesthetic techniques

时间窗: Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes

This will be measured by a blinded panel of audiologist review the two ABR click test results and provide judgment at each intensity level, for each ear and whether or not a response is present.

次要结局

  • Amplitude of Wave V of the ABR after broadband click stimulus(Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes)
  • Latency of Wave V of the ABR after broadband click stimulus(Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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