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

Auditory Brainstem Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830815
• Other study ID #: 2015-8186
• Status: Completed
• Start date: June 2016
• Est. completion date: November 27, 2018

Study information

• Verified date: June 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Auditory Brainstem Response

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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