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

Phase 3

Completed

• Conditions: Anesthesia
• Interventions: Drug: Rocuronium bromide; Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT00988520
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.6 mg/kg intubation dose under sevoflurane	Rocuronium bromide	-
0.6 mg/kg intubation dose under sevoflurane	Sevoflurane	-
0.9 mg/kg intubation dose under sevoflurane	Rocuronium bromide	-
continuous dose following 0.6 mg/kg intubation dose + propofol	Rocuronium bromide	-
continuous dose following 0.6 mg/kg intubation dose + propofol	Propofol	-
0.9 mg/kg intubation dose under sevoflurane	Sevoflurane	-
continuous dose following 0.9 mg/kg intubation dose + propofol	Rocuronium bromide	-
continuous dose following 0.9 mg/kg intubation dose + propofol	Propofol	-

Primary Outcome Measures

Name	Time	Method
Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg	90 minutes after start of continuous infusion