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History of Changes for Study: NCT02368782
Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children (OAE)
Latest version (submitted February 15, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 15, 2015 None (earliest Version on record)
Comparison Format:

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Study NCT02368782
Submitted Date:  February 15, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 30112011
Brief Title: Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children (OAE)
Official Title: Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children With Normal Hearing Tests Undergoing Adenoidectomy and Tonsillectomy
Secondary IDs: 36171 [Other Grant/Funding Number: ─▒stanbul University Scientific Research Department]
Open or close this module Study Status
Record Verification: February 2015
Overall Status: Completed
Study Start: December 2013
Primary Completion: January 2015 [Actual]
Study Completion: January 2015 [Actual]
First Submitted: August 27, 2014
First Submitted that
Met QC Criteria:
February 15, 2015
First Posted: February 23, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 15, 2015
Last Update Posted: February 23, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Istanbul University
Responsible Party: Principal Investigator
Investigator: Prof. Dr. A. Pervin SUTAS BOZKURT
Official Title: Prof. Dr.
Affiliation: Istanbul University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.

Detailed Description:
Open or close this module Conditions
Conditions: Normal Healthy Ears
Ketamine and Propofol Effects on Hemodynamics
Ketamine and Propofol Effects on TEOAE and DPOAE
Keywords: transient evoked otoacoustic emissions
distortion product otoacoustic emissions
ketamine
propofol
child
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 30 [Actual]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
ketamine group
ketamine 2mg/kg bolus IV once
propofol group
propofol 2mg/kg ıv bolus once
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Study Population: children ages 4-15 years ASA I-II Tonsillectomy and/or adenoidectomy Normal ear hearing tests
Sampling Method: Non-Probability Sample
Minimum Age: 4 Years
Maximum Age: 15 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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,

Open or close this module Contacts/Locations
Locations: Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey, 34303
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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