We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00984633
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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
Muscle Relaxation Drug: Rocuronium bromide (Org 9426) Drug: Sevoflurane Drug: Propofol Phase 3

Study Type : Interventional  (Clinical Trial)
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 : June 2003
Primary Completion Date : December 2003
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00984633     History of Changes
Other Study ID Numbers: P05976
71102
First Posted: September 25, 2009    Key Record Dates
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