The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org
9426 in maintenance of muscle relaxation in adult subjects undergoing general elective
surgery.
Inclusion Criteria:
- Subjects at least 20 but under 65 years of age.
- Subjects of asa class 1, 2 or 3 for general elective surgery.
- Subjects who are not considered to be pregnant.
- Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia,
with anticipated duration of surgery of about 1. 5-3 hours.
- Subjects with normal laboratory values for serum electrolytes (Na+, K+, Cl-), BUN,
creatinine, total bilirubin, ALP, ALAT and ASAT as judged by the investigator or the
sub-investigator.
- Subjects who received an explanation of the trial and agreed informed consent in
writing to participate in the trial in advance.
Exclusion Criteria:
- Subjects with renal dysfunction as a complication or in the history.
- Subjects with serum creatinine level greater than 1. 6 mg/dL.
- Subjects with severe hepatic dysfunction as a complication or in the history.
- Subjects with known significant metabolic or neuromuscular disorders.
- Subjects with showing dyspnea, airway obstruction or bronchial asthma.
- Subjects with a history of hypersensitivity to pancuronium bromide, vecuronium
bromide or bromine.
- Subjects with atopic diseases.
- Subjects who have developed any systemic allergic symptoms.
- Subjects receiving antihistamines and antiallergic agents for 1 month or more.
- Subjects receiving any of the following drugs known to affect on the action of
neuromuscular blocking agents on surgery day: calcium antagonists; anticonvulsants;
aminoglycoside antibiotics; polypeptide antibiotics; or metronidazole.
- Subjects under hypothermic anesthesia.
- Subjects who participated as research subjects in another trial within the last 6
months or is now participating in other trials.
- Other subjects judged to be ineligible as subjects in this trial by the discretion of
the investigator or the sub-investigator.
