UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of female sex hormone change during menstrual cycle on propofol pharmacokinetics and pharmacodynamics
Title of the study (Brief title)	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	Atusko Tomita
Organization	National Defense Medical College
Division name	Anesthesiology
Address	3-2, Namiki, Tokorozawa-shi, Saitama
TEL	0429-95-1511
Email	con155@ndmc.ac.jp

Public contact
Name of contact person	Atsuko Tomita
Organization	National Defense Medical College
Division name	Anesthesiology
Address	3-2, Namiki, Tokorozawa-shi, Saitama
TEL	0429-95-1511
Homepage URL
Email	con155@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020966