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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00984633
Collaborator
(none)
40
Enrollment
4
Arms
6
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Dec 1, 2003
Actual Study Completion Date :
Dec 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: 0.6 mg/kg intubation dose + sevoflurane

Drug: Rocuronium bromide (Org 9426)
0.6 mg/kg injection intubation dose
Other Names:
  • SCH 900085

    • Drug: Sevoflurane
    0.5-2.0% intravenous maintenance anesthesia
    Other Names:
  • Sevofrane

    		•
    Experimental: 0.9 mg/kg intubation dose + sevoflurane

    Drug: Rocuronium bromide (Org 9426)
    0.9 mg/kg injection intubation dose
    Other Names:
  • SCH 900085

    • Drug: Sevoflurane
    0.5-2.0% intravenous maintenance anesthesia
    Other Names:
  • Sevofrane

    		•
    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: Propofol
    4-10 mg/kg/hr maintenance anesthesia
    Other Names:
  • Diprivan

    		•
    Experimental: 0.9 mg/kg intubation dose + propofol

    Drug: Rocuronium bromide (Org 9426)
    0.9 mg/kg injection intubation dose
    Other Names:
  • SCH 900085

    • Drug: Propofol
    4-10 mg/kg/hr maintenance anesthesia
    Other Names:
  • Diprivan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation [Time from intubating dose to bolus maintenance dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00984633
    Other Study ID Numbers:
    • P05976
    • 71102
    First Posted:
    Sep 25, 2009
    Last Update Posted:
    May 12, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Merck Sharp & Dohme LLC
    Neuromuscular Blocking Agents
    Additional relevant MeSH terms:
    Bromides
    Propofol
    Sevoflurane
    Rocuronium

    Study Results

    No Results Posted as of May 12, 2015