UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010725 |
|---|---|
| Receipt number | R000012533 |
| Scientific Title | Reducing pain of microemulsion propofol injection: a double blind randomized study of three methods of tourniquet and lidocaine |
| Date of disclosure of the study information | 2013/05/15 |
| Last modified on | 2014/04/28 10:03:12 |
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Basic information
Public title
Reducing pain of microemulsion propofol injection: a double blind randomized study of three methods of tourniquet and lidocaine
Acronym
Microemulsion propofol injection pain: effect of tourniquet and lidocaine
Scientific Title
Reducing pain of microemulsion propofol injection: a double blind randomized study of three methods of tourniquet and lidocaine
Scientific Title:Acronym
Microemulsion propofol injection pain: effect of tourniquet and lidocaine
Region
| Asia(except Japan) |
Condition
Condition
elective surgery
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we evaluated the effect of different methods of tourniquet application and lidocaine on microemulsion propofol injection pain in this study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduce the incidence and intensity of microemulsion propofol injection pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
lidocaine with tourniquet under arm down (vein engorgement state)
Interventions/Control_2
lidocaine with tourniquet under arm up(vein gravity drainage)
Interventions/Control_3
Tourniquet under arm down(vein engorgement state)
Interventions/Control_4
contol
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ASA physica status 1 or 2 patients aged between 18 and 65 years scheduled for elective surgery
Key exclusion criteria
patints with known hypersensitivity to lidocaine or microemulsion propofol, impaired communication, a renal, hepatic, cardiac, or neurologic problem, or a hypovolemic state and those who refused to provide informed consent were excluded.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Il-Ok Lee |
Organization
Korea University
Division name
Anesthesiology and Pain Medicine
Zip code
Address
Gurodong-ro 148, Guro-gu, Seoul, Korea
TEL
82-8-2626-3234
iloklee@korea.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Il-Ok Lee |
Organization
Korea University
Division name
Anesthesiology and Pain Medicine
Zip code
Address
Gurodong-ro 148, Guro-ku, Seoul, Republic of Korea
TEL
82-2-2626-3234
Homepage URL
iloklee@korea.ac.kr
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
Funding Source
Organization
Korea University
Organization
Division
Category of Funding Organization
Outside Japan
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 | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2013 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 15 | Day |
Last modified on
| 2014 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012533
