Status:
COMPLETED
Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 (Study P05977)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anesthesia
Eligibility:
All Genders
20-64 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the infusion rate of Org 9426 following intubating dose of Org 9426 0.6 mg/kg or 0.9 mg/kg in adult surgical patients.
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 2-5 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 related to drugs or general anesthesia.
- 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 sub-investigator.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00988520
Start Date
May 1 2003
End Date
September 1 2003
Last Update
May 12 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.