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

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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Relaxation
• Intervention / Treatment: Drug: Sevoflurane; Drug: Rocuronium bromide (Org 9426); Drug: Rocuronium bromide (Org 9426); Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (ACTUAL): December 1, 2003
• Study Completion (ACTUAL): December 1, 2003

Study Registration Dates

• First Submitted: September 24, 2009
• First Submitted That Met QC Criteria: September 24, 2009
• First Posted (ESTIMATE): September 25, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Neuromuscular Blocking Agents
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anticonvulsants; Anesthetics, Inhalation; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Propofol; Sevoflurane; Bromides; Rocuronium
• Other Study ID Numbers: P05976; 71102