UMIN-CTR Clinical Trial

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

Contact us.