UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of rapid fluid infusion on predicted plasma concentration of propofol
Title of the study (Brief title)	Effect of rapid fluid infusion on predicted plasma concentration of propofol
Region	Japan

Condition
Condition	patient undergoing elective surgery under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim is to examine the accuracy of predicted plasma concentration of propofol during and after rapid fluid infusion.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	time course of measured plasma concentration divided by predicted plasma concentration of propofol
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	maintenance infusion for less than half an hour
Interventions/Control_2	rapid crystalloid infusion for less than half an hour
Interventions/Control_3	rapid colloid infusion for less than half an hour
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	patients undergoing elective surgery under general anesthesia
Key exclusion criteria	neurologic disorder; significant heart, respiratory, hepatic, or renal imparement cardiovascular disease; recent use of psychoactive medicine; body mass index greater than 30
Target sample size	50

Research contact person
Name of lead principal investigator	Kenichi Masui
Organization	National Defense Medical College Hospital
Division name	Department of Anesthesiology
Address	Namiki 3-2, Tokorozawa, Saitama, Japan
TEL	04-2995-1511
Email	kenichi@masuinet.com

Public contact
Name of contact person	Kenichi Masui
Organization	National Defense Medical College
Division name	Department of Anesthesiology
Address	Namiki 3-2, Tokorozawa, Saitama, Japan
TEL	04-2995-1511
Homepage URL
Email	kenichi@masuinet.com

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College and Departmental Funding
Organization
Division
Category of Funding Organization
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	2010 Year 10 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 04 Month 01 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry	2011 Year 03 Month 01 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 10 Month 07 Day
Last modified on	2017 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005209