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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00984633
First received: September 24, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation [ Time Frame: Time from intubating dose to bolus maintenance dose ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00984633     History of Changes
Other Study ID Numbers: P05976, 71102
Study First Received: September 24, 2009
Last Updated: May 7, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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

ClinicalTrials.gov processed this record on September 18, 2014