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

Completed

• Conditions: Auditory Brainstem Response

• Registration Number: NCT02830815
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Primary Completion: 2018-11-27
• Study Completion: 2018-11-27
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative interpretability of ABR testing in the same patient undergoing two anesthetic techniques	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States