UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019925 |
|---|---|
| Receipt number | R000023005 |
| Scientific Title | The influence of differences in solvents and concentration on the efficacy of propofol at an induction of anesthesia |
| Date of disclosure of the study information | 2015/11/25 |
| Last modified on | 2015/11/25 11:51:17 |
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Basic information
Public title
The influence of differences in solvents and concentration on the efficacy of propofol at an induction of anesthesia
Acronym
The differences in solvents and concentration of propofol
Scientific Title
The influence of differences in solvents and concentration on the efficacy of propofol at an induction of anesthesia
Scientific Title:Acronym
The differences in solvents and concentration of propofol
Region
| Japan |
Condition
Condition
Surgical case
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to compare the efficacy of propofol of different laboratories (AstraZeneca and Maruishi) and different concentrations (1- and 2%-Maruishi) during the induction of anesthesia.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The required dose of propofol at the induction of anesthesia.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The patients of group D1 were received AstraZeneca Diprivan 1% at a rate of 40 mg/kg/h. Group M1 was administered 1%-Maruishi and group M2 was administered 2%-Maruishi at the same rate of propofol.
Interventions/Control_2
The patients of group D1 were received AstraZeneca Diprivan 1% at a rate of 40 mg/kg/h. Group M1 was administered 1%-Maruishi and group M2 was administered 2%-Maruishi at the same rate of propofol.
Interventions/Control_3
The patients of group D1 were received AstraZeneca Diprivan 1% at a rate of 40 mg/kg/h. Group M1 was administered 1%-Maruishi and group M2 was administered 2%-Maruishi at the same rate of propofol.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Surgical patients.
Key exclusion criteria
The patients with severe preoperative complications.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yushi Adachi |
Organization
Hamamatsu University School of Medicine
Division name
Intensive Care Unit
Zip code
Address
1-20-1 Handayama, Hamamatsu city
TEL
053-435-2286
yuadachi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yushi Adachi |
Organization
Hamamatsu University School of Medicine
Division name
Intensive Care Unit
Zip code
Address
1-20-1, Handayama, Hamamatsu city
TEL
053-436-2286
Homepage URL
yuadachi.ccm@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2008 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 25 | Day |
Last modified on
| 2015 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023005
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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