Unique ID issued by UMIN | UMIN000022300 |
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Receipt number | R000025693 |
Scientific Title | Assessment of the reduced injection pain of the newly developed formation of the rocuronium |
Date of disclosure of the study information | 2016/05/20 |
Last modified on | 2018/11/14 13:56:53 |
Assessment of the reduced injection pain of the newly developed formation of the rocuronium
Assessment of injection pain of rocuronium
Assessment of the reduced injection pain of the newly developed formation of the rocuronium
Assessment of injection pain of rocuronium
Japan |
Patients requiring general anesthesia
Anesthesiology |
Others
NO
We will investigate injection associated pain will be reduced in newly developed formula of roculonium, comparing to the eslax, currently available formula of roculonium. Primary outcome will be a frequency of the withdrawal response of upper arm 3 minutes after the drug injection. Secondary outcomes will be the magnitude of the withdrawal response, change of blood pressure and heart rate.
Efficacy
frequency of the withdrawal response of upper arm 3 minutes after the drug injection.
magnitude of the withdrawal response, change of blood pressure and heart rate 3 minutes after the drug injection.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
After the induction of general anesthesia, newly developed form of roculonium (0.9mg/Kg) will be injected intravenously.
After the induction of general anesthesia, eslax (0.9mg/Kg) will be injected intravenously.
1 | years-old | <= |
65 | years-old | >= |
Male and Female
Patients who will receive elective surgery under general anesthesia and obtained written informed consent about this study.
Muscular disease
Known allergy against eslax, propofol
Muscle weakness of upper arm
Obesity (BMI>30%)
150
1st name | |
Middle name | |
Last name | Fumimasa Amaya |
Kyoto Prefectural University of Medicine
Department of Anesthesiology
Kajiicho 465 Kamigyo-ku Kyoto
075-251-5633
ama@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Fumimasa Amaya |
Kyoto Prefectural University of Medicine
Department of Anesthesiology
Kajiicho 465 Kamigyo-ku Kyoto
075-251-5633
ama@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
Maruishi Pharmaceutical Co.Ltd
Fuji Phrama Co., Ltd.
Profit organization
NO
2016 | Year | 05 | Month | 20 | Day |
Unpublished
Completed
2016 | Year | 05 | Month | 11 | Day |
2017 | Year | 08 | Month | 07 | Day |
2016 | Year | 05 | Month | 13 | Day |
2018 | Year | 11 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025693
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