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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009940
Receipt No. R000011645
Scientific Title Influence of time of day on propofol dose for anesthesia induction
Date of disclosure of the study information 2013/02/06
Last modified on 2017/06/12

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Basic information
Public title Influence of time of day on propofol dose for anesthesia induction
Acronym Chronopharmacology of propofol
Scientific Title Influence of time of day on propofol dose for anesthesia induction
Scientific Title:Acronym 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
1st name
Middle name
Last name Masahiro Murakawa
Organization Fukushima Medical University
Division name Anesthesiology, School of Medicine
Zip code
Address 1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL 0245471111ext.2464
Email masui@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinju Obara
Organization Fukushima Medical University
Division name Anesthesiology, School of Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2013 Year 01 Month 28 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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