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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019925
Receipt No. 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

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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
Last 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
Email yuadachi@hama-med.ac.jp

Public contact
1st 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
Email yuadachi.ccm@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023005

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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