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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
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Scientific title
Menstrual cycle effects on perioperative thermoregulation in women undergoing general anaesthesia
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Secondary ID [1]
284231
0
none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
perioperative thermoregulation and postanesthetic shivering
291344
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Condition category
Condition code
Anaesthesiology
291707
291707
0
0
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Other anaesthesiology
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Reproductive Health and Childbirth
291742
291742
0
0
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Menstruation and menopause
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
288937
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Not applicable
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Comparator / control treatment
none
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
291645
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peroperative body temparature changes monitored continuously with transdermal heat probes.
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Assessment method [1]
291645
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Timepoint [1]
291645
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monitored continuously when participant is under general anaesthesia
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Secondary outcome [1]
307220
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Postanesthetic shivering was evaluated by 4 degree scale
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Assessment method [1]
307220
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Timepoint [1]
307220
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at the end of the operation after extubation
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Eligibility
Key inclusion criteria
women ages between 18-45 who received general anesthesia for elective surgey
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
menstural irregularities
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Random sample
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Timing
Both
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
26/01/2014
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Date of last participant enrolment
Anticipated
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Actual
2/06/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
5880
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Turkey
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State/province [1]
5880
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istanbul
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Funding & Sponsors
Funding source category [1]
288859
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Self funded/Unfunded
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Name [1]
288859
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Address [1]
288859
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Country [1]
288859
0
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Primary sponsor type
Individual
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Name
veysel erden
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Address
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
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Country
Turkey
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Secondary sponsor category [1]
287555
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None
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Name [1]
287555
0
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Address [1]
287555
0
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Country [1]
287555
0
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
perioperative thermoregulation and postanesthetic shivering grade were observed in women who received general ansthesia
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
46818
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A/Prof VEYSEL ERDEN
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Address
46818
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Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
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Country
46818
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Turkey
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Phone
46818
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+902124590000
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Fax
46818
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Email
46818
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[email protected]
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Contact person for public queries
Name
46819
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CIHAN GULER
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Address
46819
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Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
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Country
46819
0
Turkey
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Phone
46819
0
+902124596990
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Fax
46819
0
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Email
46819
0
[email protected]
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Contact person for scientific queries
Name
46820
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CIHAN GULER
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Address
46820
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Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
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Country
46820
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Turkey
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Phone
46820
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+902124596990
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Fax
46820
0
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Email
46820
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Menstrual Cycle Phase May Effect the Thermoregulation during Anesthesia
2018
https://doi.org/10.23937/2377-4630/1410073
N.B. These documents automatically identified may not have been verified by the study sponsor.
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