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

NCT00988520 | Completed Phase 3 DMC

• 2 other identifiers: P0597771103
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Keywords

Neuromuscular Blocking Agents

Outcome Measures

Primary Outcomes (1)

• Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg

  90 minutes after start of continuous infusion

Study Arms (4)

0.6 mg/kg intubation dose under sevoflurane

EXPERIMENTAL

Drug: Rocuronium bromide; Drug: Sevoflurane

0.9 mg/kg intubation dose under sevoflurane

EXPERIMENTAL

Drug: Rocuronium bromide; Drug: Sevoflurane

continuous dose following 0.6 mg/kg intubation dose + propofol

EXPERIMENTAL

Drug: Rocuronium bromide; Drug: Propofol

continuous dose following 0.9 mg/kg intubation dose + propofol

EXPERIMENTAL

Drug: Rocuronium bromide; Drug: Propofol

Interventions

Rocuronium bromide DRUG

Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation

Also known as: SCH 900085

0.6 mg/kg intubation dose under sevoflurane; 0.9 mg/kg intubation dose under sevoflurane; continuous dose following 0.6 mg/kg intubation dose + propofol; continuous dose following 0.9 mg/kg intubation dose + propofol

Sevoflurane DRUG

0.5-2.0% intravenous maintenance anesthesia

Also known as: Sevofrane

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

Propofol DRUG

4010 mg/kg/hr intravenous maintenance anesthesia

Also known as: Diprivan

continuous dose following 0.6 mg/kg intubation dose + propofol; continuous dose following 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 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.

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 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.

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: October 1, 2009
• First Posted: October 2, 2009
• Study Start: May 1, 2003
• Primary Completion: September 1, 2003
• Study Completion: September 1, 2003
• Last Updated: May 12, 2015

Record last verified: 2015-05