Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 (Study P05977) - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

Drug Information available for: Propofol Sevoflurane Rocuronium bromide Rocuronium

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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 ] [ Designated as safety issue: No ]

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

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 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

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00988520 History of Changes
Other Study ID Numbers:	P05977, 71103
Study First Received:	October 1, 2009
Last Updated:	November 2, 2009
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Schering-Plough:

Neuromuscular Blocking Agents

Additional relevant MeSH terms:

Bromides
Propofol
Sevoflurane
Neuromuscular Blocking Agents
Rocuronium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Hypnotics and Sedatives
Neuromuscular Nondepolarizing Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on June 17, 2013