UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018109 |
|---|---|
| Receipt number | R000020966 |
| Scientific Title | Influence of female sex hormone change during menstrual cycle on propofol pharmacokinetics and pharmacodynamics |
| Date of disclosure of the study information | 2015/06/26 |
| Last modified on | 2017/07/04 23:46:03 |
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Basic information
Public title
Influence of female sex hormone change during menstrual cycle on propofol
pharmacokinetics and pharmacodynamics
Acronym
influence of female menstrual cycle on propofol pharmacokinetics and pharmacodynamics
Scientific Title
Influence of female sex hormone change during menstrual cycle on propofol
pharmacokinetics and pharmacodynamics
Scientific Title:Acronym
influence of female menstrual cycle on propofol pharmacokinetics and pharmacodynamics
Region
| Japan |
Condition
Condition
Patients planning on getting surgery
under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the influence of female sex hormone change during menstrual cycle on propofol pharmacokinetics and pharmacodynamics
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
preparation of pharmacokinetic/pharmacodynamic model on female surgical patients
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1.Female patients planning surgery under general anesthesia
2.Patients who are able to provide written informed consent
Key exclusion criteria
1.Obesity
2.Pregnant women and nursing mothers
3.Postmenopausal women
4.Patients with severe liver or kidney disorder
5.Patients with neurological disorder
6.Patients taking psychotropic drugs orally
7.Patients with hypersensitivity to propofol
8.Patients who attending physicians consider to be inappropriate due to other reasons mentioned above
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atusko Tomita |
Organization
National Defense Medical College
Division name
Anesthesiology
Zip code
Address
3-2, Namiki, Tokorozawa-shi, Saitama
TEL
0429-95-1511
con155@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Tomita |
Organization
National Defense Medical College
Division name
Anesthesiology
Zip code
Address
3-2, Namiki, Tokorozawa-shi, Saitama
TEL
0429-95-1511
Homepage URL
con155@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To measure blood levels of propofol on surgical female patients, to elucidate influence of female sex hormone change during menstrual cycle on propofol pharmacokinetics and
pharmacodynamics.
Management information
Registered date
| 2015 | Year | 06 | Month | 26 | Day |
Last modified on
| 2017 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020966
