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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036931
Receipt No. R000042091
Scientific Title Protective effect of rocuronium on ischemic myocyte injury induced by tourniquet.
Date of disclosure of the study information 2019/07/26
Last modified on 2019/07/26

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Basic information
Public title Protective effect of rocuronium on ischemic myocyte injury induced by tourniquet.
Acronym Protective effect of rocuronium on ischemic myocyte injury induced by tourniquet.
Scientific Title Protective effect of rocuronium on ischemic myocyte injury induced by tourniquet.
Scientific Title:Acronym Protective effect of rocuronium on ischemic myocyte injury induced by tourniquet.
Region
Japan

Condition
Condition patients scheduled for knee arthroplasty
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of rocuronium on ischemic myocyte injury.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Amount of change in plasma malondialdehyde concentration before and after ischemia.
Key secondary outcomes 1)Changes in myoglobin, CK, AST, LDH, potassium, lactic acid, uric acid and hypoxanthine concentrations before and after ischemia.
2)Number and size of muscle contractions obtained from electromyogram and mechanomyogram during surgery.
3)Amount of change in quadriceps muscle strength before and after surgery.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rocuronium bromide (0.9 mg/kg) will be administered before ischemia.
Interventions/Control_2 Placebo (same volume of saline) will be administered before ischemia.
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria 1)Patients scheduled for knee arthroplasty.
2)Female patients aged 50-79 years old.
3)Patients who agreed to a written informed consent.
Key exclusion criteria 1)Patients with preoperative ALT > 100 U/L.
2)Patients with preoperative Cr > 1.5 mg/dL.
3)Patients with a history of neuromuscular disease.
4)Patients with drug sensitivity and allergy.
5)Pregnant women and patients who may be pregnant or breast-feeding patients.
6)Patients receiving medications known to interact with muscle relaxants.
7)Patients who are judged to be inappropriate.
Target sample size 46

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Mizobuchi
Organization Kobe University Hospital
Division name Department of Anesthesiology
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
TEL 078-382-6172
Email anesth@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Shinya
Middle name
Last name Taguchi
Organization Kobe university graduate school of medicine
Division name Division of anesthesiology, Department of surgery related
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
TEL 078-382-6172
Homepage URL
Email shitaguchi39@gmail.com

Sponsor
Institute Kobe university
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe University Clinical Research Ethical Committee
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
Tel 078-382-6669
Email kainyu@med.kobe-u.ac.jp

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 神戸大学医学部附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 26 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
2019 Year 06 Month 01 Day
Date of IRB
2019 Year 07 Month 19 Day
Anticipated trial start date
2019 Year 07 Month 26 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 03 Day
Last modified on
2019 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042091

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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