UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009894 |
|---|---|
| Receipt number | 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 17:06:01 |
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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
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
bokuaiji@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011583
