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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
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 |
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 |
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Condition | ||
Condition | patients scheduled for knee arthroplasty | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_9 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 46 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
anesth@med.kobe-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |