UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010886 |
|---|---|
| Receipt number | R000012741 |
| Scientific Title | Effect of sedation with a combination of intravenous propofol and inhaled nitrous oxide |
| Date of disclosure of the study information | 2013/06/06 |
| Last modified on | 2014/03/18 10:15:00 |
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Basic information
Public title
Effect of sedation with a combination of intravenous propofol and inhaled nitrous oxide
Acronym
Sedation with a combination of intravenous propofol and inhaled nitrous oxide
Scientific Title
Effect of sedation with a combination of intravenous propofol and inhaled nitrous oxide
Scientific Title:Acronym
Sedation with a combination of intravenous propofol and inhaled nitrous oxide
Region
| Japan |
Condition
Condition
patiants who need intravanous sedation during dental procedure
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether combination technique of inhaled nitrous oxide and intravenous propofol can improve adverse reaction of intravenous sedation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
circulationdynamics, depth of sedation, adverse effect
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sedation with propofol
Interventions/Control_2
sedation with propofol and nitrous oxide
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
Adult patiants, ASA physical status 1 or 2, who need intravenous sedation for dental procedure
Key exclusion criteria
patiants contraindicated to use ofpropofol or nitrous oxide
ASA physical status 3 or 4
aged over 70 years
aged under 20 years
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chizuko Yokoe |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of dental anesthesiology
Zip code
Address
1-8, Yamadaoka, Suita City, Osaka, Japan
TEL
06-6879-2972
yokoe@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chizuko Yokoe |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of dental anesthesiology
Zip code
Address
1-8, Yamadaoka, Suita City, Osaka, Japan
TEL
06-6879-2972
Homepage URL
yokoe@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate 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
| 2013 | Year | 06 | Month | 06 | 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
| 2010 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 22 | 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 | 06 | Month | 05 | Day |
Last modified on
| 2014 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012741
