UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009940 |
|---|---|
| Receipt number | 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 07:48:07 |
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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
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
shinjn@fmu.ac.jp
Sponsor or person
Institute
Anesthesiology, Fukushima Medical University School of Medicine
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011645
