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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009894
Receipt No. R000011583
Scientific Title Examining the optimum dose of midazolam required for the vasalgia amnesia at the time of propofol infusion according to an age.
Date of disclosure of the study information 2013/01/29
Last modified on 2015/02/02

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Basic information
Public title Examining the optimum dose of midazolam required for the vasalgia amnesia at the time of propofol infusion according to an age.
Acronym propofol vasalgia
Scientific Title Examining the optimum dose of midazolam required for the vasalgia amnesia at the time of propofol infusion according to an age.
Scientific Title:Acronym propofol vasalgia
Region
Japan

Condition
Condition Healthy Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In intra venous anesthesia at dental-surgery, midazolam and propofol are generally used as temperantia. Propofol gives vasalgia at the time of infusion, and remains as sometimes unpleasant reminiscence. On the other hand, since midazolam generally has an antegrade amnestic effect,it is possible to vanish unpleasant reminiscence including vasalgia. But, midazolam has respiratory depressant action by airway obstruction. If it stands on the viewpoint of the use by ambulatories, or relieve of respiratory depression, the effective dose which can vanish unpleasantness reminiscence and does not cause the respiratory depression was desired.However the dose of midazolam was determined experientially until now.Then,we planned examining the optimum dose of midazolam required for the vasalgia amnesia at the time of a propofol infusion according to an age.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Examining the optimum dose of midazolam required for the vasalgia amnesia at the time of propofol infusion according to an age
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Prescription of midazolam according to updown method before infusion of propofol
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
70 years-old >
Gender Male and Female
Key inclusion criteria Healthy adult
ASA PS 1
Key exclusion criteria Obesity
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Boku Aiji
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthesiology
Zip code
Address 1-8, Yamadaoka, Suita, Japan
TEL 06-6879-2972
Email bokuaiji@dent.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Boku Aiji
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthesiology
Zip code
Address 1-8 Yamadaoka Suita Japan
TEL 06-6879-2972
Homepage URL
Email bokuaiji@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Dentistry
Institute
Department

Funding Source
Organization Osaka University Graduate School of Dentistry
Organization
Division
Category of Funding Organization Other
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 01 Month 29 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 Completed
Date of protocol fixation
2012 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 29 Day
Last modified on
2015 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011583

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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