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

NCT00984633 | Completed Phase 3 DMC

• 2 other identifiers: P0597671102
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Muscle Relaxation

Keywords

Neuromuscular Blocking Agents

Outcome Measures

Primary Outcomes (1)

• Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation

  Time from intubating dose to bolus maintenance dose

Study Arms (4)

0.6 mg/kg intubation dose + sevoflurane

EXPERIMENTAL

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

0.9 mg/kg intubation dose + sevoflurane

EXPERIMENTAL

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

0.6 mg/kg intubation dose + propofol

EXPERIMENTAL

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

0.9 mg/kg intubation dose + propofol

EXPERIMENTAL

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

Interventions

Rocuronium bromide (Org 9426) DRUG

0.6 mg/kg injection intubation dose

Also known as: SCH 900085

0.6 mg/kg intubation dose + propofol; 0.6 mg/kg intubation dose + sevoflurane

Sevoflurane DRUG

0.5-2.0% intravenous maintenance anesthesia

Also known as: Sevofrane

0.6 mg/kg intubation dose + sevoflurane; 0.9 mg/kg intubation dose + sevoflurane

Propofol DRUG

4-10 mg/kg/hr maintenance anesthesia

Also known as: Diprivan

0.6 mg/kg intubation dose + propofol; 0.9 mg/kg intubation dose + propofol

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Interventions

Rocuronium; Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: June 1, 2003
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: May 12, 2015

Record last verified: 2015-05