UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013944 |
|---|---|
| Receipt number | R000013937 |
| Scientific Title | The comparison of synergistic effects between clindamycin and cefazolin on rocuronium-induced neuromuscular blockade |
| Date of disclosure of the study information | 2014/05/16 |
| Last modified on | 2014/05/13 14:14:15 |
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Basic information
Public title
The comparison of synergistic effects between clindamycin and cefazolin on rocuronium-induced neuromuscular blockade
Acronym
The comparison of synergistic effects between antimicrobials
Scientific Title
The comparison of synergistic effects between clindamycin and cefazolin on rocuronium-induced neuromuscular blockade
Scientific Title:Acronym
The comparison of synergistic effects between antimicrobials
Region
| Japan |
Condition
Condition
The patients who will undergo exodontia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The comparison of synergistic effects between antimicrobials
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time under the effect of muscle relaxants
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antimicrobials (single dose)
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who will undergo exodontia with general anesthesia.
American society of anesthesiologist physical status (ASA-PS) is 1-2.
Key exclusion criteria
The patients who have over 120 kg of body weight.
the patients who have an allergy of antimicrobials.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YOSHINOBU KIMURA |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
Address
S1W16 chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
chiro1123@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YOSHINOBU KIMURA |
Organization
Sapporo Medical University school of medicine
Division name
Anesthesiology
Zip code
Address
S1W16 chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
chiro1123@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NONE
Organization
Division
Category of Funding Organization
Other
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 | 05 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 12 | 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
| 2014 | Year | 05 | Month | 13 | Day |
Last modified on
| 2014 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013937
