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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anesthesia

Intervention: Rocuronium bromide (Drug); Rocuronium bromide (Drug); Rocuronium bromide (Drug); Sevoflurane (Drug); Propofol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

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.

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

Primary outcome: Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg

Eligibility

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: May 2003
Last updated: May 11, 2015

Page last updated: August 23, 2015

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