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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010725
Receipt No. 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

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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
Email 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
Email iloklee@korea.ac.kr

Sponsor
Institute Korea University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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