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

Study Overview
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Brief Summary
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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.

Official Title
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Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 Following a Single Intubating Dose in Adult Subjects Undergoing Operation Under Sevoflurane or Propofol Anesthesia

Conditions
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Muscle Relaxation

Intervention / Treatment
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* Drug: Rocuronium bromide (Org 9426)
* Drug: Rocuronium bromide (Org 9426)
* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.6 mg/kg intubation dose + sevoflurane<br> | Drug: Rocuronium bromide (Org 9426)<br>* 0.6 mg/kg injection intubation dose<br>* Other names: SCH 900085;Drug: Sevoflurane<br>* 0.5-2.0% intravenous maintenance anesthesia<br>* Other names: Sevofrane;|
| Experimental: 0.9 mg/kg intubation dose + sevoflurane<br> | Drug: Rocuronium bromide (Org 9426)<br>* 0.9 mg/kg injection intubation dose<br>* Other names: SCH 900085;Drug: Sevoflurane<br>* 0.5-2.0% intravenous maintenance anesthesia<br>* Other names: Sevofrane;|
| Experimental: 0.6 mg/kg intubation dose + propofol<br> | Drug: Rocuronium bromide (Org 9426)<br>* 0.6 mg/kg injection intubation dose<br>* Other names: SCH 900085;Drug: Propofol<br>* 4-10 mg/kg/hr maintenance anesthesia<br>* Other names: Diprivan;|
| Experimental: 0.9 mg/kg intubation dose + propofol<br> | Drug: Rocuronium bromide (Org 9426)<br>* 0.9 mg/kg injection intubation dose<br>* Other names: SCH 900085;Drug: Propofol<br>* 4-10 mg/kg/hr maintenance anesthesia<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation |  | Time from intubating dose to bolus maintenance dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromuscular Blocking Agents