UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039668 |
|---|---|
| Receipt number | R000045223 |
| Scientific Title | Comparison of recovery time after intravenous sedation using dexmedetomidine in combination with propofol or midazolam |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2022/09/02 19:19:01 |
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Basic information
Public title
Comparison of recovery time after intravenous sedation using dexmedetomidine in combination with propofol or midazolam
Acronym
Comparison of intravenous sedation using dexmedetomidine in combination with propofol or midazolam
Scientific Title
Comparison of recovery time after intravenous sedation using dexmedetomidine in combination with propofol or midazolam
Scientific Title:Acronym
Comparison of intravenous sedation using dexmedetomidine in combination with propofol or midazolam
Region
| Japan |
Condition
Condition
Require dental procedure under intravenous sedation
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare recovery time and body movements between dexmedetomidine-midazolam and dexmedetomidine-propofol sedation in patients undergo dental procesure under intravenous sedation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from the end of the sedatives administration until the Romberg test is successfully performed.
Key secondary outcomes
Time from the end of the sedatives administration until achieving an Aldrete score of 9 or 10.
Time from the end of the sedatives administration until patients possible to sit.
Time from the end of the sedatives administration until patients possible to stand up.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sedation with dexmedetomidine and propofol
Interventions/Control_2
Sedation with dexmedetomidine and midazolam
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Require dental procedure under intravenous sedation
2. From 20 to 65 years of age
3. American Society of Anesthesiologists (ASA) physical status 1 or 2
Key exclusion criteria
1. A history of allergic reactions to the drugs used in this study
2. Allergic reaction to yolk and soy
3. Hepatic or renal dysfunction
4. Maternal and nursing women
5. Circulatory or respiratory dysfunction
6. Acute narrow-angle glaucoma
7. Myasthenia gravis
8. Receiving HIV protease inhibitors or HIV reverse transcriptase inhibitors
9. Prescribed antipsychotics
10. brain disorder
11. Severe obesity, micrognathia, tonsillar hypertrophy, sleep apnea syndrome
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hanamoto |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthesiology
Zip code
565-0871
Address
1-8, Yamadaoka, suita, Osaka, Japan
TEL
06-6879-2972
hanamoto@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hanamoto |
Organization
Department of Dental Anesthesiology
Division name
1-8, Yamadaoka, suita, Osaka, Japan
Zip code
565-0871
Address
1-8, Yamadaoka, suita, Osaka, Japan
TEL
0668792972
Homepage URL
hanamoto@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education,Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Graduate School of Dentistry General Affairs Section
Address
1-8, Yamadaoka, suita, Osaka, Japan
Tel
06-6879-2831
si-soumu-syomu@office.osaka-u.ac.jp
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
| 2020 | Year | 03 | Month | 04 | 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
| 2020 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045223
