UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015674 |
|---|---|
| Receipt number | R000018215 |
| Scientific Title | A research for the application of pregabalin for anesthesia and interaction of pregabalin and anesthetic agent |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2014/12/01 09:51:24 |
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Basic information
Public title
A research for the application of pregabalin for anesthesia and interaction of pregabalin and anesthetic agent
Acronym
A research for the application of pregabalin for anesthesia and interaction of pregabalin and anesthetic agent
Scientific Title
A research for the application of pregabalin for anesthesia and interaction of pregabalin and anesthetic agent
Scientific Title:Acronym
A research for the application of pregabalin for anesthesia and interaction of pregabalin and anesthetic agent
Region
| Japan |
Condition
Condition
condition which needs operation under anesthesia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the interaction of pregabalin with major anesthetic agent, propofol and perioperative analgesic effect of pregabalin for the purpose of application of the drug for sedation and general anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood concentration of propofol to acheive the sufficient sedative level during intravenous sedation
Key secondary outcomes
Circulation and respiration dynamics during intravenous sedation, perioperative analgesic effect, first propofol injection-induced pain and side effects at 30 minutes and 1hour after pregabalin administration, and 30 minutes. 1 hour and 5 hour after the intravenous sedation end.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Perform the intravenous sedation three times on separate days: first without pregabalin, second oral premadication of pregabalin 100mg and third oral pregabalin 200mg taken 1 hour before the intravenous sedation. Each intravenous sedation was performed at the intervals of 1 week or more.
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were without any clinical history, ASA physical status 1, and 20s to 30s male and female. After obtaining the written informed consent, we performed blood examination and electrocardiogram for health check.
Key exclusion criteria
Volunteers were excluded from recruitment if they were allergic to egg, soy and milk, allergic to any antibiotics or painkiller, chronic neuralgia patients, taking any GABA derivatives, or had dental disease that might cause severe pain
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Ito |
Organization
Faculty of Dental Science, Kyushu University
Division name
Department of Dental Anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku, Fukuoka, Japan
TEL
+81-92-642-6480
ito@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Karube |
Organization
Faculty of Dental Science, Kyushu University
Division name
Department of Dental Anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku, Fukuoka, Japan
TEL
+81-92-642-6480
Homepage URL
karuby.n@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Dental Science, Kyushu University, Department of Dental Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Scientific reserch fundation
Organization
Division
Category of Funding Organization
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 | 12 | Month | 01 | 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
| 2013 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 12 | Day |
Last modified on
| 2014 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018215
