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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011252
Receipt No. R000012523
Scientific Title The effect of circadian rhythm on the propofol dose required for loss of consciousness
Date of disclosure of the study information 2013/07/23
Last modified on 2015/04/06

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Basic information
Public title The effect of circadian rhythm on the propofol dose required for loss of consciousness
Acronym Circadian rhythm for propofol
Scientific Title The effect of circadian rhythm on the propofol dose required for loss of consciousness
Scientific Title:Acronym Circadian rhythm for propofol
Region
Japan

Condition
Condition patients under general anesthesia
Classification by specialty
Surgery in general Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 circadian rhythm for propofol
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes time of loss of consciousness after administration
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 Male and Female
Key inclusion criteria ASA physical status 1
Key exclusion criteria except above
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kumiko Tanabe
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address Gifu City, Yanagido 1-1
TEL 058-230-6404
Email kumiko-t@m2.gyao.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kumiko Tanabe
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address Gifu City, Yanagido 1-1
TEL 058-230-6404
Homepage URL
Email kumiko-t@m2.gyao.ne.jp

Sponsor
Institute University Graduate School of Medicine
Department of Anesthesiology and Pain MedicineGifu
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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The concentration for LOC by propofol is notinfluenced by the time of day, at least during the human active
period.
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 Main results already published
Date of protocol fixation
2013 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 15 Day
Last follow-up date
2014 Year 08 Month 31 Day
Date of closure to data entry
2014 Year 08 Month 31 Day
Date trial data considered complete
2014 Year 08 Month 31 Day
Date analysis concluded
2014 Year 09 Month 15 Day

Other
Other related information Propofol was administered intravenously using the Diprifusor system, which is a target-controlled infusion system of proposal, through an intravenous catheter place in the patient' forearm. The proposal infusion started with an initial effect-site concentration or 4 micro g/mL for 3 min and increased in increments of 0.5 micro g/mL every 30 sec after the first 3 min until the patient lost their consciousness. Th predicted blood concentration and the predicted effect-site concentration of propofol required for loss of consciousness were recorded.

Management information
Registered date
2013 Year 07 Month 23 Day
Last modified on
2015 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012523

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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