A Phase II Study of MR19A13A.
- Conditions
- Patients undergoing a scheduled surgery under general anesthesia.
- Registration Number
- JPRN-jRCT2051220112
- Lead Sponsor
- obuyo Oya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method