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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Muscle Relaxation

Treatments: Drug: Rocuronium bromide (Org 9426); Drug: Sevoflurane; Drug: Propofol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984633

P05976

71102

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

0.6 mg/kg intubation dose + sevoflurane

Experimental group

Treatment:

Drug: Rocuronium bromide (Org 9426)

Drug: Rocuronium bromide (Org 9426)

Drug: Sevoflurane

0.9 mg/kg intubation dose + sevoflurane

Experimental group

Treatment:

Drug: Rocuronium bromide (Org 9426)

Drug: Rocuronium bromide (Org 9426)

Drug: Sevoflurane

0.6 mg/kg intubation dose + propofol

Experimental group

Treatment:

Drug: Rocuronium bromide (Org 9426)

Drug: Rocuronium bromide (Org 9426)

Drug: Propofol

0.9 mg/kg intubation dose + propofol

Experimental group

Treatment:

Drug: Rocuronium bromide (Org 9426)

Drug: Rocuronium bromide (Org 9426)

Drug: Propofol