Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)
NCT ID: NCT00984633
Last Updated: 2015-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2003-06-30
2003-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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0.6 mg/kg intubation dose + sevoflurane
Rocuronium bromide (Org 9426)
0.6 mg/kg injection intubation dose
Sevoflurane
0.5-2.0% intravenous maintenance anesthesia
0.9 mg/kg intubation dose + sevoflurane
Rocuronium bromide (Org 9426)
0.9 mg/kg injection intubation dose
Sevoflurane
0.5-2.0% intravenous maintenance anesthesia
0.6 mg/kg intubation dose + propofol
Rocuronium bromide (Org 9426)
0.6 mg/kg injection intubation dose
Propofol
4-10 mg/kg/hr maintenance anesthesia
0.9 mg/kg intubation dose + propofol
Rocuronium bromide (Org 9426)
0.9 mg/kg injection intubation dose
Propofol
4-10 mg/kg/hr maintenance anesthesia
Interventions
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Rocuronium bromide (Org 9426)
0.6 mg/kg injection intubation dose
Rocuronium bromide (Org 9426)
0.9 mg/kg injection intubation dose
Sevoflurane
0.5-2.0% intravenous maintenance anesthesia
Propofol
4-10 mg/kg/hr maintenance anesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
64 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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71102
Identifier Type: -
Identifier Source: secondary_id
P05976
Identifier Type: -
Identifier Source: org_study_id
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