Unique ID issued by UMIN | UMIN000036931 |
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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 |
Protective effect of rocuronium on ischemic myocyte injury induced by tourniquet.
Protective effect of rocuronium on ischemic myocyte injury induced by tourniquet.
Protective effect of rocuronium on ischemic myocyte injury induced by tourniquet.
Protective effect of rocuronium on ischemic myocyte injury induced by tourniquet.
Japan |
patients scheduled for knee arthroplasty
Orthopedics |
Others
NO
To assess the effect of rocuronium on ischemic myocyte injury.
Efficacy
Confirmatory
Explanatory
Phase II,III
Amount of change in plasma malondialdehyde concentration before and after ischemia.
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.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Rocuronium bromide (0.9 mg/kg) will be administered before ischemia.
Placebo (same volume of saline) will be administered before ischemia.
50 | years-old | <= |
80 | years-old | > |
Female
1)Patients scheduled for knee arthroplasty.
2)Female patients aged 50-79 years old.
3)Patients who agreed to a written informed consent.
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.
46
1st name | Satoshi |
Middle name | |
Last name | Mizobuchi |
Kobe University Hospital
Department of Anesthesiology
650-0017
7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
078-382-6172
anesth@med.kobe-u.ac.jp
1st name | Shinya |
Middle name | |
Last name | Taguchi |
Kobe university graduate school of medicine
Division of anesthesiology, Department of surgery related
650-0017
7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
078-382-6172
shitaguchi39@gmail.com
Kobe university
Japan society for the promotion of science
Japanese Governmental office
Kobe University Clinical Research Ethical Committee
7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
078-382-6669
kainyu@med.kobe-u.ac.jp
NO
神戸大学医学部附属病院(兵庫県)
2019 | Year | 07 | Month | 26 | Day |
Unpublished
Completed
2019 | Year | 06 | Month | 01 | Day |
2019 | Year | 07 | Month | 19 | Day |
2019 | Year | 07 | Month | 26 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 06 | Month | 30 | Day |
2019 | Year | 06 | Month | 03 | Day |
2023 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042091
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