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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013944
Receipt No. 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

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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
Email 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
Email chiro1123@gmail.com

Sponsor
Institute Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013937

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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