Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000345684
Ethics application status
Not required
Date submitted
22/03/2014
Date registered
1/04/2014
Date last updated
30/07/2018
Type of registration
N/A

Titles & IDs
Public title
The effect of gender on perioperative thermoregulation
Scientific title
The effect of gender on perioperative thermoregulation in patients undergoing general anaesthesia
Secondary ID [1] 284311 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perioperative thermoregulation 291459 0
postanesthetic shivering 291461 0
Condition category
Condition code
Anaesthesiology 291829 291829 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Body temperature changes observed perioperatively during both men and women are under general anaesthesia and postanesthetic shivering seen at the end of the operation after extubation was evaluated by 4 degree scale in five minutes at recovery room.
Intervention code [1] 289033 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291748 0
peroperative body temparature changes monitored continuously with transdermal heat probes.
Timepoint [1] 291748 0
monitored continuously when participant is under general anaesthesia
Secondary outcome [1] 307407 0
Postanesthetic shivering was evaluated by 4 degree scale
Timepoint [1] 307407 0
at the end of the operation after extubation

Eligibility
Key inclusion criteria
Patients ages between 18-45 who received general anesthesia for elective surgey
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
oral contraceptive pills usage
morbid obesity
Younger than 18 years old
Elder than 45 years old

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
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Withdrawn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
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5917 0
Turkey
State/province [1] 5917 0
istanbul

Funding & Sponsors
Funding source category [1] 288951 0
Self funded/Unfunded
Name [1] 288951 0
Country [1] 288951 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] 287631 0
None
Name [1] 287631 0
Address [1] 287631 0
Country [1] 287631 0

Ethics approval
Ethics application status
Not required

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

Contacts
Principal investigator
Name 47150 0
A/Prof VEYSEL ERDEN
Address 47150 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 47150 0
Turkey
Phone 47150 0
+902124590000
Fax 47150 0
Email 47150 0
[email protected]
Contact person for public queries
Name 47151 0
CIHAN GULER
Address 47151 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 47151 0
Turkey
Phone 47151 0
+90 212 459 68 55
Fax 47151 0
Email 47151 0
[email protected]
Contact person for scientific queries
Name 47152 0
CIHAN GULER
Address 47152 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 47152 0
Turkey
Phone 47152 0
+90 212 459 68 55
Fax 47152 0
Email 47152 0
[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.