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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Auditory Brainstem Response

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative interpretability of ABR testing in the same patient undergoing two anesthetic techniques | 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. | Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Broadband click stimulus testing, General Anesthesia, Sevoflurane, Propofol, Amplitude latency, Wave V