Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)

Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 Following a Single Intubating Dose in Adult Subjects Undergoing Operation Under Sevoflurane or Propofol Anesthesia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00984633

Enrollment

Registered

2009-09-25

Start date

2003-06-30

Completion date

2003-12-31

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

Muscle Relaxation

Keywords

Neuromuscular Blocking Agents

Brief summary

The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org 9426 in maintenance of muscle relaxation in adult subjects undergoing general elective surgery.

Interventions

DRUGRocuronium bromide (Org 9426)

0.6 mg/kg injection intubation dose

DRUGSevoflurane

0.5-2.0% intravenous maintenance anesthesia

DRUGPropofol

4-10 mg/kg/hr 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 about 1.5-3 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. * 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 the sub-investigator.

Design outcomes

Primary

Measure	Time frame
Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation	Time from intubating dose to bolus maintenance dose

Outcome results

None listed

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