Clinical trial NCT02830815: Comparative Effects of Two Anesthetic Techniques on Auditory Brain Response in Children
Official title: Comparative Effects of Two Anesthetic Techniques on Auditory Brain Response in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Auditory Brainstem Response
Keywords: Broadband click stimulus testing
General Anesthesia
Sevoflurane
Propofol
Amplitude latency
Wave V
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 80
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the radiology ABR schedule

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.

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

Primary outcomes:
measure: Qualitative interpretability of ABR testing in the same patient undergoing two anesthetic techniques
timeFrame: Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes
Secondary outcomes:
measure: Amplitude of Wave V of the ABR after broadband click stimulus
timeFrame: Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes
measure: Latency of Wave V of the ABR after broadband click stimulus
timeFrame: Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Ali Kandil, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.