Status:
COMPLETED
Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Muscle Relaxation
Eligibility:
All Genders
20-64 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00984633
Start Date
June 1 2003
End Date
December 1 2003
Last Update
May 12 2015
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