Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 (Study P05977)

Study Overview
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Brief Summary
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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.

Official Title
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Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 Following a Single Intubating Dose in Adult Patients Undergoing Operation Under Sevoflurane or Propofol Anesthesia.

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Rocuronium bromide
* Drug: Rocuronium bromide
* Drug: Rocuronium bromide
* 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 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 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 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.

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 under sevoflurane<br> | Drug: Rocuronium bromide<br>* Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation<br>* Other names: SCH 900085;Drug: Rocuronium bromide<br>* Intubation dose of 0.6 mg/kg injection<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 under sevoflurane<br> | Drug: Rocuronium bromide<br>* Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation<br>* Other names: SCH 900085;Drug: Rocuronium bromide<br>* Intubation dose of 0.9 mg/kg injection<br>* Other names: SCH 900085;Drug: Sevoflurane<br>* 0.5-2.0% intravenous maintenance anesthesia<br>* Other names: Sevofrane;|
| Experimental: continuous dose following 0.6 mg/kg intubation dose + propofol<br> | Drug: Rocuronium bromide<br>* Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation<br>* Other names: SCH 900085;Drug: Rocuronium bromide<br>* Intubation dose of 0.6 mg/kg injection<br>* Other names: SCH 900085;Drug: Propofol<br>* 4010 mg/kg/hr intravenous maintenance anesthesia<br>* Other names: Diprivan;|
| Experimental: continuous dose following 0.9 mg/kg intubation dose + propofol<br> | Drug: Rocuronium bromide<br>* Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation<br>* Other names: SCH 900085;Drug: Rocuronium bromide<br>* Intubation dose of 0.9 mg/kg injection<br>* Other names: SCH 900085;Drug: Propofol<br>* 4010 mg/kg/hr intravenous maintenance anesthesia<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg |  | 90 minutes after start of continuous infusion | 

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