UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetics of fentanyl administered to epidural space
Title of the study (Brief title)	Pharmacokinetics of fentanyl administered to epidural space
Region	Japan

Condition
Condition	Patients undergoing elective surgery under general and epidural anesthesia
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the time course of plasma concentration of fentanyl administered to epidural space
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	plasma concentration of fentanyl
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing elective surgery under general and epidural anesthesia
Key exclusion criteria	Severe cardiac, hepatic, or renal disease, body mass index equal or greater than 35, and allergy to fentanyl or local anesthetics
Target sample size	30

Research contact person
Name of lead principal investigator	Masui, Kenichi
Organization	National Defense Medical College
Division name	Anesthesiology
Address	Namiki 3-2, Tokorozawa, Saitama, Japan
TEL	04-2995-1692
Email	kenichi@masuinet.com

Public contact
Name of contact person	Masui, Kenichi
Organization	National Defense Medical College
Division name	Anesthesiology
Address	Namiki 3-2, Tokorozawa, Saitama, Japan
TEL	04-2995-1692
Homepage URL
Email	kenichi@masuinet.com

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 Year 04 Month 11 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 10 Month 15 Day
Anticipated trial start date	2015 Year 03 Month 09 Day
Last follow-up date
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	Fentanyl is administered epirulally as necessary for surgery. Arterial blood samples are drawn every 3 to 120 minutes.

Management information
Registered date	2017 Year 04 Month 11 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020506