UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011252 |
|---|---|
| Receipt number | 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 | 2019/06/12 12:57:10 |
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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
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Gifu City, Yanagido 1-1
TEL
058-230-6404
kumiko-t@m2.gyao.ne.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Gifu City, Yanagido 1-1
TEL
058-230-6404
Homepage URL
kumiko-t@m2.gyao.ne.jp
Sponsor or person
Institute
University Graduate School of Medicine
Department of Anesthesiology and Pain MedicineGifu
Institute
Department
Personal name
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
Gifu University Graduate School of Medicine
Address
Gifu City, Yanagido 1-1
Tel
058-230-6404
kumiko-t@m2.gyao.ne.jp
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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 06 | 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
| 2019 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012523
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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