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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00988520

Enrollment

Registered

2009-10-02

Start date

2003-05-31

Completion date

2003-09-30

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Neuromuscular Blocking Agents

Brief 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.

Interventions

DRUGRocuronium bromide

Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation

DRUGSevoflurane

0.5-2.0% intravenous maintenance anesthesia

DRUGPropofol

4010 mg/kg/hr intravenous maintenance anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026