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OpenTrials
Completed

NCT Number: NCT02368782

Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children

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.

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Key information

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34303, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children With Normal Hearing Tests Undergoing Adenoidectomy and Tonsillectomy

Acronym: OAE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 23, 2015
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.