UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of time of day on propofol dose for anesthesia induction
Title of the study (Brief title)	Chronopharmacology of propofol
Region	Japan

Condition
Condition	All 90 subjects were ASA physical status I or II, between the ages of 18 and 65 years, and were scheduled for elective procedures under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The hypothesis is that the propofol dose for anesthesia induction is affected by the time of day.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Total propofol induction dose required to achieve loss of consciousness (LOC) Time to LOC
Key secondary outcomes	None

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	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects whose ASA physical status I or II, and were scheduled for elective procedures under general anesthesia. Written informed consent will be obtained.
Key exclusion criteria	1) Allergy to propofol and/or eggs 2) History of neuropsychiatric disorders 3) Taking mind-altering drugs 4) Obese patients whose Body Mass Index are more than 35 kg/m2 5) Hypertension, diabetes, endocrine diseases 6) Deafness
Target sample size	90

Research contact person
Name of lead principal investigator	Masahiro Murakawa
Organization	Fukushima Medical University
Division name	Anesthesiology, School of Medicine
Address	1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL	0245471111ext.2464
Email	masui@fmu.ac.jp

Public contact
Name of contact person	Shinju Obara
Organization	Fukushima Medical University
Division name	Anesthesiology, School of Medicine
Address	1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL	0245471111ext.2464
Homepage URL
Email	shinjn@fmu.ac.jp

Sponsor
Institute	Anesthesiology, Fukushima Medical University School of Medicine
Institute
Department

Funding Source
Organization	None
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	福島県立医科大学附属病院（福島県）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 01 Month 28 Day
Anticipated trial start date	2013 Year 01 Month 28 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective observational study The grouping factor is the time of day The outcomes were described in the "Assessment" section.

Management information
Registered date	2013 Year 02 Month 03 Day
Last modified on	2017 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011645