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

Anesthesia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988520
• Other study ID #: P05977
• Secondary ID: 71103
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2009
• Last updated: May 11, 2015
• Start date: May 2003
• Est. completion date: September 2003

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Rocuronium bromide
Continuous intravenous infusion initiated at 7 µg/kg/min and adjusted to maintain muscle relaxation
• Rocuronium bromide
Intubation dose of 0.6 mg/kg injection
• Rocuronium bromide
Intubation dose of 0.9 mg/kg injection
• Sevoflurane
0.5-2.0% intravenous maintenance anesthesia
• Propofol
4010 mg/kg/hr intravenous maintenance anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg		90 minutes after start of continuous infusion	No