Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000758606
Ethics application status
Approved
Date submitted
24/06/2014
Date registered
17/07/2014
Date last updated
17/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Sevoflurane and Desflurane on otoacoustic emissions (OAE) in healthy adult patients with normal hearing tests undergoing septoplasty and turbinoplasty surgery
Scientific title
Effects of Sevoflurane and Desflurane on otoacoustic emissions (OAE) in healthy adult patients with normal hearing tests undergoing septoplasty and turbinoplasty surgery
Secondary ID [1] 284215 0
29112011
Universal Trial Number (UTN)
U1111-1158-3595
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otoacoustic emissions in healthy adult patients before, during and following anaesthesia with normal hearing tests 292270 0
Condition category
Condition code
Anaesthesiology 292626 292626 0 0
Anaesthetics
Ear 292627 292627 0 0
Normal ear development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 289674 0
Treatment: Drugs
Comparator / control treatment
control measurement - before the start of inhalation agents while the patient is awake
Control group
Active

Outcomes
Primary outcome [1] 292466 0
overall transient evoked otoacoustic emissions (TEOAEs) measured by Madsen Capella-otoacoustic emissions testing OAE system module version 2.12 software (Denmark)
Timepoint [1] 292466 0
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.
Primary outcome [2] 292467 0
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)
Timepoint [2] 292467 0
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.
Secondary outcome [1] 309031 0
nil
Timepoint [1] 309031 0
nil

Eligibility
Key inclusion criteria
Healthy patients with normal hearing tests who underwent septoplasty and turbinoplasty surgery
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Three dB Change in TEOAE's and DpOAE's considered relevant. Preinduction measurements at all variables varied from 10-19dB. The minimum changes of these parameters were 15%. At confidence level of 95% and confidence interval 15 % sample size of measurements calculated 22 patients each ear (44 ears) being measured.
One-factor, repeated measures ANOVA
Linear regressions
Unpaired t- test with repeated measures on the time factor

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2011
Actual
20/06/2012
Date of last participant enrolment
Anticipated
29/03/2013
Actual
28/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 6175 0
Turkey
State/province [1] 6175 0

Funding & Sponsors
Funding source category [1] 289484 0
Self funded/Unfunded
Name [1] 289484 0
nil
Country [1] 289484 0
Primary sponsor type
Individual
Name
Gurcan Gungor
Address
Istanbul University Cerrahpasa Medical Faculty Dept of Anesthesiology and Reanimation
Fatih- ISTANBUL 34303 TURKEY
Country
Turkey
Secondary sponsor category [1] 288168 0
None
Name [1] 288168 0
Address [1] 288168 0
Country [1] 288168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291240 0
Istanbul University Cerrahpas Medical Faculty Clinical Research Ethic Committee
Ethics committee address [1] 291240 0
Ethics committee country [1] 291240 0
Turkey
Date submitted for ethics approval [1] 291240 0
17/11/2011
Approval date [1] 291240 0
29/11/2011
Ethics approval number [1] 291240 0
43441

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 104 104 0 0
/AnzctrAttachments/365922-OAE etik resmi.docx
Attachments [2] 106 106 0 0
/AnzctrAttachments/365922-RSS Feed.docx

Contacts
Principal investigator
Name 46746 0
Dr Gurcan Gungor
Address 46746 0
Istanbul University Cerrahpasa Medical Faculty, Dept of Anaesthesiology Fatih- Istanbul 34303 TURKEY
Country 46746 0
Turkey
Phone 46746 0
+905326424355
Fax 46746 0
+902125733314
Email 46746 0
[email protected];[email protected]
Contact person for public queries
Name 46747 0
Gurcan Gungor
Address 46747 0
Istanbul University Cerrahpasa Medical Faculty, Dept of Anaesthesiology
Fatih- Istanbul 34303 TURKEY
Country 46747 0
Turkey
Phone 46747 0
+905326424355
Fax 46747 0
+902125733314
Email 46747 0
[email protected];[email protected]
Contact person for scientific queries
Name 46748 0
Gurcan Gungor
Address 46748 0
Istanbul University Cerrahpasa Medical Faculty, Dept of Anaesthesiology
Fatih- Istanbul 34303 TURKEY
Country 46748 0
Turkey
Phone 46748 0
+905326424355
Fax 46748 0
+902125733314
Email 46748 0
[email protected];[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.