Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children (OAE)
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|ClinicalTrials.gov Identifier: NCT02368782|
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Otoacoustic emissions (OAEs) are non-invasive, easy to apply and objective test methods which are widely used to determine the presence of hearing in audiology clinics. Under some circumstances and children, the study should be applied under general anaesthesia. The aim of this study was to find out the influence of propofol (P) and ketamine (K) on OAE measurements. .
Methods: Thirty- healthy children who will underwent adenoidectomy and tonsillectomy will be included in this study after Institutional ethics committee approval and informed consent of parents. Children will be evaluated one day before surgery by tympanometry. Psychologically prepared children will be admitted to the operating room. Following EMLA (Eutectic Mixture of Local Anesthetics ) cream application IV line will be inserted. ECG and non-invasive blood pressure will be monitored. Transient evoked otoacoustic emissions (TEOAEs) and distortion product otoacoustic emissions (DPOAEs) will measured in both ears of each patient (n=20 ears) prior to P or K administration( Pre-P and Pre-K). Propofol will be given 2mg/kg or ketamine 2mg/kg intravenously and 40% O2 in air will be given by mask ventilation. Five minutes later TEOAE and DPOAE measurements will be repeated (Post-P and Post-K). After this measurement the routine general anaesthesia and surgical protocol will be commenced. Heart rate, blood pressures TEOAE and DPOAE measurements will be compared at pre and post stages by paired Student's t- test.
|Condition or disease|
|Normal Healthy Ears Ketamine and Propofol Effects on Hemodynamics Ketamine and Propofol Effects on TEOAE and DPOAE|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children With Normal Hearing Tests Undergoing Adenoidectomy and Tonsillectomy|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
ketamine 2mg/kg bolus IV once
propofol 2mg/kg ıv bolus once
- DPOAE and TEOAE [ Time Frame: Pre and post propofol or ketamine administration ]Before and after the administration of propofol or ketamine measurements of DPOAE and TEOAE will be performed
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): NCT02368782
|Istanbul University Cerrahpasa Medical Faculty|
|Istanbul, Turkey, 34303|