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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988520
First Posted: October 2, 2009
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Anesthesia Drug: Rocuronium bromide Drug: Sevoflurane Drug: Propofol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 Following a Single Intubating Dose in Adult Patients Undergoing Operation Under Sevoflurane or Propofol Anesthesia.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg [ Time Frame: 90 minutes after start of continuous infusion ]

Enrollment: 38
Study Start Date: May 2003
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.6 mg/kg intubation dose under sevoflurane Drug: Rocuronium bromide
Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation
Other Name: SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.6 mg/kg injection
Other Name: SCH 900085
Drug: Sevoflurane
0.5-2.0% intravenous maintenance anesthesia
Other Name: Sevofrane
Experimental: 0.9 mg/kg intubation dose under sevoflurane Drug: Rocuronium bromide
Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation
Other Name: SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.9 mg/kg injection
Other Name: SCH 900085
Drug: Sevoflurane
0.5-2.0% intravenous maintenance anesthesia
Other Name: Sevofrane
Experimental: continuous dose following 0.6 mg/kg intubation dose + propofol Drug: Rocuronium bromide
Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation
Other Name: SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.6 mg/kg injection
Other Name: SCH 900085
Drug: Propofol
4010 mg/kg/hr intravenous maintenance anesthesia
Other Name: Diprivan
Experimental: continuous dose following 0.9 mg/kg intubation dose + propofol Drug: Rocuronium bromide
Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation
Other Name: SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.9 mg/kg injection
Other Name: SCH 900085
Drug: Propofol
4010 mg/kg/hr intravenous maintenance anesthesia
Other Name: Diprivan

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00988520     History of Changes
Other Study ID Numbers: P05977
71103
First Submitted: October 1, 2009
First Posted: October 2, 2009
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Neuromuscular Blocking Agents

Additional relevant MeSH terms:
Propofol
Sevoflurane
Rocuronium
Bromides
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Anticonvulsants