NCT02830815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

June 29, 2016

Last Update Submit

June 30, 2021

Conditions

Auditory Brainstem Response

Keywords

Broadband click stimulus testingGeneral AnesthesiaSevofluranePropofolAmplitude latencyWave V

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from the radiology ABR schedule

You may qualify if:

  • years old
  • ASA status I, II, or III
  • Scheduled for ABR with general anesthesia

You may not qualify if:

  • Contraindication to sevoflurane or propofol
  • ASA \>3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45339, United States

Location

Related Publications (1)

  • 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.

    PMID: 35113042DERIVED

Study Officials

  • Ali Kandil, DO

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 13, 2016

Study Start

June 1, 2016

Primary Completion

November 27, 2018

Study Completion

November 27, 2018

Last Updated

July 2, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)