UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007513 |
|---|---|
| Receipt number | R000008793 |
| Scientific Title | A comperison of Dexmedetomidine and Propofol for sedation in patients undergoing dental treatment |
| Date of disclosure of the study information | 2012/03/15 |
| Last modified on | 2012/03/15 12:24:35 |
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Basic information
Public title
A comperison of Dexmedetomidine and Propofol for sedation in patients undergoing dental treatment
Acronym
A comperison of Dexmedetomidine and Propofol for sedation in patients undergoing dental treatment
Scientific Title
A comperison of Dexmedetomidine and Propofol for sedation in patients undergoing dental treatment
Scientific Title:Acronym
A comperison of Dexmedetomidine and Propofol for sedation in patients undergoing dental treatment
Region
| Japan |
Condition
Condition
patients undergoing dental treatment
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
provide sedation more safely for patients undergoing dental treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
percutaneous oxygen saturation, time to go home, patient satisfaction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administer propofol 0.7mg/kg for 10 minutes and then 0.5-2mg/kg/h
Interventions/Control_2
administer dexmedetomidine 6mcg/kg for 10 minutes and then 0.2-0.6mcg/kg/h
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
ASA1-2, Patients undergoing dental treatment in operating room under local anesthesia
Key exclusion criteria
impaired hepatic function, BMI>30, drugs affecting effect of sedatives
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujii Tatsuya |
Organization
Higashi Omiya General Hospital
Division name
Department of Anesthesiology and Critical Care
Zip code
Address
5-18 Higashi Omiya, Minuma, Saitama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Higashi Omiya General Hospital
Division name
Department of Anesthesiology and Critical Care
Zip code
Address
5-18 Higashi Omiya, Minuma, Saitama
TEL
Homepage URL
Sponsor or person
Institute
Higashi Omiya General Hospital
Institute
Department
Personal name
Funding Source
Organization
Higashi Omiya General Hospital
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
| 2012 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
| 2012 | Year | 03 | Month | 15 | Day |
Last modified on
| 2012 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008793
