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

NCT ID: NCT02830815

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-11-27

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.

Conditions

Auditory Brainstem Response

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Kandil, DO

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35113042 (View on PubMed)

Other Identifiers

2015-8186

Identifier Type: -

Identifier Source: org_study_id