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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12614000758606 |
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Date of registration:
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17/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Sevoflurane and Desflurane on otoacoustic emissions (OAE) in healthy adult patients with normal hearing tests undergoing septoplasty and turbinoplasty surgery
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Scientific title:
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Effects of Sevoflurane and Desflurane on otoacoustic emissions (OAE) in healthy adult patients with normal hearing tests undergoing septoplasty and turbinoplasty surgery |
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Date of first enrolment:
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20/06/2012 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12614000758606.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Pharmacokinetics / pharmacodynamics;
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Dr Gurcan Gungor
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Address:
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Istanbul University Cerrahpasa Medical Faculty, Dept of Anaesthesiology
Fatih- Istanbul 34303 TURKEY
Turkey |
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Telephone:
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+905326424355 |
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Email:
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gugungor@yahoo.com;gugungor@hotmail.com |
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Affiliation:
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Name:
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Dr Gurcan Gungor
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Address:
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Istanbul University Cerrahpasa Medical Faculty, Dept of Anaesthesiology
Fatih- Istanbul 34303 TURKEY
Turkey |
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Telephone:
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+905326424355 |
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Email:
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gugungor@yahoo.com;gugungor@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Healthy patients with normal hearing tests who underwent septoplasty and turbinoplasty surgery
Exclusion criteria: 1.abnormal hearing test
2. TEAOE levels less than 3 dB SPL ( decibel -Sound pressure level ) or DPOAE levels less than 6 dBSPL in the preoperative measurements
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Otoacoustic emissions in healthy adult patients before, during and following anaesthesia with normal hearing tests;
Otoacoustic emissions in healthy adult patients before, during and following anaesthesia with normal hearing tests
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Anaesthesiology - Anaesthetics
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Ear - Normal ear development and function
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Intervention(s)
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Arm 1: sevoflurane 2% by inhalation from induction until the end of the operation
Arm 2: desflurane 5% by inhalation from induction until the end of the operation
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Primary Outcome(s)
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overall transient evoked otoacoustic emissions (TEOAEs) measured by Madsen Capella-otoacoustic emissions testing OAE system module version 2.12 software (Denmark)
[3dB difference at 5min after induction, at the end of surgery under anesthesia,1 hour after surgery in the ward from preinduction. Comparison between all time points were also evaluated.]
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distortion product otoacoustic emissions (DPOAEs) at 1kH, 1,5kH, 2kH, 3kH, 4kH, 6kH, 8kH Measurement performed by Madsen Capella-otoacoustic emissions testing OAE system module version 2.12 software (Denmark)[3dB t 5min after induction, at the end of surgery under anesthesia,1 hour after surgery in the ward from preinduction. Comparison between all time points were also evaluated.]
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Secondary Outcome(s)
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nil[nil]
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Source(s) of Monetary Support
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nil
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Ethics review
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Status: Approved
Approval date:
Contact:
Istanbul University Cerrahpas Medical Faculty Clinical Research Ethic Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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