UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014228 |
|---|---|
| Receipt number | R000016488 |
| Scientific Title | The optimal standard dose of the intravenous sedation by using midazolam and propofol for dental procedure |
| Date of disclosure of the study information | 2014/06/11 |
| Last modified on | 2014/06/11 11:41:47 |
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Basic information
Public title
The optimal standard dose of the intravenous sedation by using midazolam and propofol for dental procedure
Acronym
The optimal standard dose of the intravenous sedation by using midazolam and propofol for dental procedure
Scientific Title
The optimal standard dose of the intravenous sedation by using midazolam and propofol for dental procedure
Scientific Title:Acronym
The optimal standard dose of the intravenous sedation by using midazolam and propofol for dental procedure
Region
| Japan |
Condition
Condition
Dental procedure under intravenous sedation
Classification by specialty
| Anesthesiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We attempt to define optimal but minimum doses of midazolam and propofol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient and dentist satisfaction for intravenous sedation
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
This study was a prospective study performed for a period of 16 months beginning in January 2012. First, 1 mg of midazolam was given, and the additional bolus of every 1 mg every min was allowed until adequate sedation was achieved. After induction with midazolam, maintenance of sedation was conducted with a continuous infusion of propofol during dental treatment. Propofol dose was determined to maintain a sedation level at which the patients could be roused by verbal command or physical stimulation.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Physical status of the enrolled patients are American Society of Anesthesiologists (ASA) class 1-2, aged 20 years old and above, who undergo intravenous sedation for dental procedure.
Key exclusion criteria
Those patients who have allergies to midazolam or propofol, dementia, intellectual disability or cerebral palsy, are excluded.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rikuo Masuda |
Organization
Showa University School of Dentistry
Division name
Department of Perioperative Medicine, Division of Anesthesiology
Zip code
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL
03-3787-1151
rikuo14@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rikuo Masuda |
Organization
Showa University School of Dentistry
Division name
Department of Perioperative Medicine, Division of Anesthesiology
Zip code
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL
03-3787-1151
Homepage URL
rikuo14@dent.showa-u.ac.jp
Sponsor or person
Institute
Department of Perioperative Medicine, Division of Anesthesiology, Showa University School of Dentistry
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 11 | 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
| 2011 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 27 | 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
| 2014 | Year | 06 | Month | 11 | Day |
Last modified on
| 2014 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016488
