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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

Tracking Information
First Submitted Date August 27, 2014
First Posted Date February 23, 2015
Last Update Posted Date February 23, 2015
Study Start Date December 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2015)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children
Official Title Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children With Normal Hearing Tests Undergoing Adenoidectomy and Tonsillectomy
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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population children ages 4-15 years ASA I-II Tonsillectomy and/or adenoidectomy Normal ear hearing tests
Condition
  • Normal Healthy Ears
  • Ketamine and Propofol Effects on Hemodynamics
  • Ketamine and Propofol Effects on TEOAE and DPOAE
Intervention Not Provided
Study Groups/Cohorts
  • ketamine group
    ketamine 2mg/kg bolus IV once
  • propofol group
    propofol 2mg/kg ıv bolus once
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 15, 2015)
30
Original Actual Enrollment Same as current
Actual Study Completion Date January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility 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,

Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 15 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT02368782
Other Study ID Numbers 30112011
36171 ( Other Grant/Funding Number: ıstanbul University Scientific Research Department )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof. Dr. A. Pervin SUTAS BOZKURT, Istanbul University
Study Sponsor Istanbul University
Collaborators Not Provided
Investigators Not Provided
PRS Account Istanbul University
Verification Date February 2015