Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Bromides; Propofol; Rocuronium; Sevoflurane

Criteria

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.