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OpenTrials
Completed

NCT Number: NCT02830815

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

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45339, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindication to sevoflurane or propofol
  • ASA >3

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Amplitude of Wave V of the ABR after broadband click stimulus

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

  2. Latency of Wave V of the ABR after broadband click stimulus

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2016
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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