UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004632 |
|---|---|
| Receipt number | R000005485 |
| Scientific Title | Effect of magnesium sulphate, NMDA antagonist, to tourniquet pain. |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2010/11/30 11:33:57 |
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Basic information
Public title
Effect of magnesium sulphate, NMDA antagonist, to tourniquet pain.
Acronym
Magnesium sulphate and tourniquet pain.
Scientific Title
Effect of magnesium sulphate, NMDA antagonist, to tourniquet pain.
Scientific Title:Acronym
Magnesium sulphate and tourniquet pain.
Region
| Japan |
Condition
Condition
Volunteer
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that magnesium sulphate would attenuate tourniquet pain in healthy awake volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS pain scale
Key secondary outcomes
Blood pressure and heart rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group(normal saline)
Interventions/Control_2
M1 group (magnesium, 1 g)
Interventions/Control_3
M2 group (magnesium, 2 g)
Interventions/Control_4
M4 group (magnesium, 4 g)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 22 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy volunteers. ASA physical status class I.
Key exclusion criteria
Hypertension, ischemic heart disease, deep vein thrombosis, and a past history of chronic pain, mental disorder, or substance misuse.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Satsumae |
Organization
University of Tsukuba
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
Tsukuba-city, Ibaraki.
TEL
029-853-3092
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Satsumae |
Organization
University of Tsukuba
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
TEL
029-853-3092
Homepage URL
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology and Critical Care Medicine, University of Tsukuba.
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
筑波大学
Other administrative information
Date of disclosure of the study information
| 2010 | 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
| 2007 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | 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
| 2010 | Year | 11 | Month | 30 | Day |
Last modified on
| 2010 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005485
