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

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.

Intervention / Treatment

Condition or Disease

  • Normal Healthy Ears
  • Ketamine and Propofol Effects on Hemodynamics
  • Ketamine and Propofol Effects on TEOAE and DPOAE

Phase

Study Design

Study type: OBSERVATIONAL
Status: Completed
Study results: No Results Available
Age: 4 Years to 15 Years
Enrollment: 30 (ACTUAL)
Funded by: Other
Time Perspective: Prospective
Observational Model: Cohort

Masking

Clinical Trial Dates

Start date: Dec 01, 2013
Primary Completion: Jan 01, 2015 ACTUAL
Completion Date: Jan 01, 2015 ACTUAL
Study First Posted: Feb 23, 2015 ESTIMATED
Results First Posted: Aug 31, 2020
Last Updated: Feb 15, 2015

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Eligibility Criteria

Sex: All
Minimum Age: 4
Maximum Age: 15
Healthy Volunteers: Yes

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,

Primary Outcomes
  • Before and after the administration of propofol or ketamine measurements of DPOAE and TEOAE will be performed

More Details

NCT Number: NCT02368782
Acronym: OAE
Other IDs: 30112011
Study URL: https://clinicaltrials.gov/study/NCT02368782
Last updated: Sep 29, 2023