Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000286640
Ethics application status
Approved
Date submitted
10/03/2014
Date registered
18/03/2014
Date last updated
2/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
menstrual cycle effects on perioperative thermoregulation in women
Scientific title
Menstrual cycle effects on perioperative thermoregulation in women undergoing general anaesthesia
Secondary ID [1] 284231 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perioperative thermoregulation and postanesthetic shivering 291344 0
Condition category
Condition code
Anaesthesiology 291707 291707 0 0
Other anaesthesiology
Reproductive Health and Childbirth 291742 291742 0 0
Menstruation and menopause

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 participants 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] 288937 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291645 0
peroperative body temparature changes monitored continuously with transdermal heat probes.
Timepoint [1] 291645 0
monitored continuously when participant is under general anaesthesia
Secondary outcome [1] 307220 0
Postanesthetic shivering was evaluated by 4 degree scale
Timepoint [1] 307220 0
at the end of the operation after extubation

Eligibility
Key inclusion criteria
women ages between 18-45 who received general anesthesia for elective surgey
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
menstural irregularities

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/01/2014
Date of last participant enrolment
Anticipated
Actual
2/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 5880 0
Turkey
State/province [1] 5880 0
istanbul

Funding & Sponsors
Funding source category [1] 288859 0
Self funded/Unfunded
Name [1] 288859 0
Country [1] 288859 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] 287555 0
None
Name [1] 287555 0
Address [1] 287555 0
Country [1] 287555 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
perioperative thermoregulation and postanesthetic shivering grade were observed in women who received general ansthesia
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46818 0
A/Prof VEYSEL ERDEN
Address 46818 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 46818 0
Turkey
Phone 46818 0
+902124590000
Fax 46818 0
Email 46818 0
[email protected]
Contact person for public queries
Name 46819 0
Dr CIHAN GULER
Address 46819 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 46819 0
Turkey
Phone 46819 0
+902124596990
Fax 46819 0
Email 46819 0
[email protected]
Contact person for scientific queries
Name 46820 0
Dr CIHAN GULER
Address 46820 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 46820 0
Turkey
Phone 46820 0
+902124596990
Fax 46820 0
Email 46820 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
SourceTitleYear of PublicationDOI
Dimensions AIMenstrual Cycle Phase May Effect the Thermoregulation during Anesthesia2018https://doi.org/10.23937/2377-4630/1410073
N.B. These documents automatically identified may not have been verified by the study sponsor.