UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036931
Receipt number 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 2023/06/06 22:59:49

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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)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 or person

Institute

Kobe university

Institute

Department

Personal name



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

Completed

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

2023 Year 06 Month 30 Day

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

2023 Year 06 Month 06 Day



Link to view the page

Value
https://center6.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