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

May 11, 2015 updated by: Merck Sharp & Dohme LLC

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.6 mg/kg injection
Other Names:
  • SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.9 mg/kg injection
Other Names:
  • SCH 900085
Drug: Sevoflurane
0.5-2.0% intravenous maintenance anesthesia
Other Names:
  • 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 Names:
  • SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.6 mg/kg injection
Other Names:
  • SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.9 mg/kg injection
Other Names:
  • SCH 900085
Drug: Sevoflurane
0.5-2.0% intravenous maintenance anesthesia
Other Names:
  • 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 Names:
  • SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.6 mg/kg injection
Other Names:
  • SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.9 mg/kg injection
Other Names:
  • SCH 900085
Drug: Propofol
4010 mg/kg/hr intravenous maintenance anesthesia
Other Names:
  • 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 Names:
  • SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.6 mg/kg injection
Other Names:
  • SCH 900085
Drug: Rocuronium bromide
Intubation dose of 0.9 mg/kg injection
Other Names:
  • SCH 900085
Drug: Propofol
4010 mg/kg/hr intravenous maintenance anesthesia
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg
Time Frame: 90 minutes after start of continuous infusion
90 minutes after start of continuous infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimate)

October 2, 2009

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05977
  • 71103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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