Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02830815
Enrollment
80
Registered
2016-07-13
Start date
2016-06-30
Completion date
2018-11-27
Last updated
2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Brainstem Response

Keywords

Broadband click stimulus testing, General Anesthesia, Sevoflurane, Propofol, Amplitude latency, Wave V

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.

Interventions

None listed

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Qualitative interpretability of ABR testing in the same patient undergoing two anesthetic techniquesParticipants will be followed for the duration of the ABR test approximately 60 - 90 minutesThis 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

MeasureTime frame
Amplitude of Wave V of the ABR after broadband click stimulusParticipants will be followed for the duration of the ABR test approximately 60 - 90 minutes
Latency of Wave V of the ABR after broadband click stimulusParticipants will be followed for the duration of the ABR test approximately 60 - 90 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026