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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
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. A. Pervin SUTAS BOZKURT, Istanbul University

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
ketamine group
ketamine 2mg/kg bolus IV once
propofol group
propofol 2mg/kg ıv bolus once



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children ages 4-15 years ASA I-II Tonsillectomy and/or adenoidectomy Normal ear hearing tests
Criteria

Inclusion Criteria:

children ages 4-15 years ASA ( American Society of Anesthesiologists) I-II Tonsillectomy and/or adenoidectomy Normal ear hearing tests

Exclusion Criteria:

Abnormal hearing tests Abnormal laboratory (Electrolyte imbalance, anemia, polycythemia, thrombocytopenia, leucopenia , leucocytosis) Congenital abnormalities and previous systemic diseases Hypo or hyperthermia Ear operations Long term fasting, dehydration or over hydration Upper respiratory disease, acute or chronic otitis,


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): NCT02368782


Locations
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Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey, 34303
Sponsors and Collaborators
Istanbul University
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Responsible Party: Prof. Dr. A. Pervin SUTAS BOZKURT, Prof. Dr., Istanbul University
ClinicalTrials.gov Identifier: NCT02368782    
Other Study ID Numbers: 30112011
36171 ( Other Grant/Funding Number: ıstanbul University Scientific Research Department )
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015
Keywords provided by Prof. Dr. A. Pervin SUTAS BOZKURT, Istanbul University:
transient evoked otoacoustic emissions
distortion product otoacoustic emissions
ketamine
propofol
child