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.

Study Overview

• Status: Completed
• Conditions: Auditory Brainstem Response

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45339
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the radiology ABR schedule

Description

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 Plan

How is the study designed?

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Ali Kandil, DO, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• Kandil AI, Ok MS, Baroch KA, Subramanyam R, Mahmoud MA, McAuliffe JJ 3rd. Why a Propofol Infusion Should Be the Anesthetic of Choice for Auditory Brainstem Response Testing in Children. Anesth Analg. 2022 Apr 1;134(4):802-809. doi: 10.1213/ANE.0000000000005693.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): November 27, 2018
• Study Completion (Actual): November 27, 2018

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Propofol; Sevoflurane; General Anesthesia; Broadband click stimulus testing; Amplitude latency; Wave V
• Other Study ID Numbers: 2015-8186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO