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

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ClinicalTrials.gov Identifier: NCT02830815
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Comparative Effects of Two Anesthetic Techniques on Auditory Brain Response in Children
Study Start Date : June 2016
Actual Primary Completion Date : November 27, 2018
Actual Study Completion Date : November 27, 2018



Primary Outcome Measures :
  1. Qualitative interpretability of ABR testing in the same patient undergoing two anesthetic techniques [ Time Frame: Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes ]
    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.


Secondary Outcome Measures :
  1. Amplitude of Wave V of the ABR after broadband click stimulus [ Time Frame: Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes ]
  2. Latency of Wave V of the ABR after broadband click stimulus [ Time Frame: Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the radiology ABR schedule
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830815


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45339
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Ali Kandil, DO Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02830815    
Other Study ID Numbers: 2015-8186
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Broadband click stimulus testing
General Anesthesia
Sevoflurane
Propofol
Amplitude latency
Wave V
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs