Patients undergoing a scheduled surgery under general anesthesia.
Conditions
Sponsors
Nobuyo Oya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese Patients aged from 6 months to 16 years, at the time of informed consent. 2) Patients with written consent from their legal representatives; If the patient is over 7 years, it is desirable to obtain the assent also from the patient as possible.
Exclusion criteria
Exclusion criteria: 1) Patients with the history of hypersensitivity or suspected hypersensitivity to any ingredients of the study drug. 2) Patients with acute angle-closure glaucoma. 3) Patients with myasthenia gravis. 4) Patients receiving the drug containing HIV protease inhibitors, efavirenz, or cobicistat. 5) Patients receiving St. John's wort supplement and are unable to discontinue taking the supplement from 1 week prior to the start of study drug administration up to 8 hours after the completion of study drug administration. 6) Patients with shock, coma, or acute alcohol intoxication with suppressed vital signs. 7) Patients with severe hepatic, renal, cardiovascular, gastrointestinal, or hematological disorders. 8) Patients using or expected to use artificial heart-lungs during the surgery. 9) Patients expected to receive blood transfusion during or after the surgery (up to 8 hours after completion of the study drug administration) 10) Patients with airway problems, such as upper airway stenosis including tonsillar hypertrophy, difficult airways, etc. 11) Patients with respiratory function disorder, such as lung disease, scoliosis, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics 1) Plasma concentration and Pharmacokinetic parameters of unchanged MR19A13A and its metabolites. Safety 1) Adverse events and adverse reaction 2) Laboratory tests 3) Vital signs systolic blood pressure, diastolic blood pressure, pulse rate 4) SpO2, respiratory rate 5) electrocardiogram | — |
Contacts
Public ContactClinical Study Unit
Maruishi Pharmaceutical Co., Ltd.
Outcome results
None listed