Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000331639
Ethics application status
Not required
Date submitted
23/02/2014
Date registered
27/03/2014
Date last updated
30/07/2018
Type of registration
N/A

Titles & IDs
Public title
The effect of anesthesia administration via a face mask on olfactory function
Scientific title
Does the use of face masks to administer general anesthesia affect the olfactory function of patients undergoing elective surgery?
Secondary ID [1] 284152 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
olfactory function 291235 0
Condition category
Condition code
Anaesthesiology 291580 291580 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
patients who received general anesthesia administration via a face mask, post-operative olfactory function compared with pre-operative olfactory function with a smell test (connecticut chemosensory clinical research center) form assessed immediately before the beginning of operation and assessed once at 5 months after completion of the operation.
Intervention code [1] 288845 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291533 0
Post-operative change in olfactory functions with a smell test (connecticut chemosensory clinical research center) in patients administered anesthesia via a face mask
Timepoint [1] 291533 0
assessed once at 5 months after completion of operation.
Secondary outcome [1] 306986 0
none
Timepoint [1] 306986 0
none

Eligibility
Key inclusion criteria
Adult patients age within 20-60 undergoing elective surgery with anesthesia applied via a face mask
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with known olfactory trouble
acute/chronic rhinosinusitis
smoking
nasal polyps
nasal tumor
disorders that may cause olfactory trouble (kallman, turner)
head trauma
septum deviation

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5848 0
Turkey
State/province [1] 5848 0
istanbul

Funding & Sponsors
Funding source category [1] 288778 0
Self funded/Unfunded
Name [1] 288778 0
Country [1] 288778 0
Primary sponsor type
Individual
Name
veysel erden
Address
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country
Turkey
Secondary sponsor category [1] 287476 0
None
Name [1] 287476 0
Address [1] 287476 0
Country [1] 287476 0

Ethics approval
Ethics application status
Not required

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46474 0
A/Prof VEYSEL ERDEN
Address 46474 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 46474 0
Turkey
Phone 46474 0
+90 212 459 60 00
Fax 46474 0
Email 46474 0
v_erden@hotmail.com
Contact person for public queries
Name 46475 0
CIHAN GULER
Address 46475 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 46475 0
Turkey
Phone 46475 0
+90 212 459 68 55
Fax 46475 0
Email 46475 0
cianguler@gmail.com
Contact person for scientific queries
Name 46476 0
CIHAN GULER
Address 46476 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 46476 0
Turkey
Phone 46476 0
+90 212 459 68 55
Fax 46476 0
Email 46476 0
cianguler@gmail.com

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.