The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation in term neonates (birth to <28 days old), infants and toddlers (28 days to less than or equal to 24 months old), children (2 years to less than or equal to 11 years of age), and adolescents (>11 years to less than or equal to 17 years of age).

Condition	Intervention	Phase
Anesthesia	Drug: Rocuronium bromide	Phase III

Ages Eligible for Study:  up to  17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: Male and female subjects from birth up to 17 years of age who are scheduled for surgery with an anticipated duration of anesthesia of about 2 hours or more requiring a maintenance muscle relaxation dose(s).

Exclusion Criteria: Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trials will not be allowed to enter.

Please refer to this study by ClinicalTrials.gov identifier  NCT00124735

Peter Kubiak, Ph.D.      973-324-6619    p.kubiak@organonusa.com

California
      Organon Investigational Site, Stanford,  California,  94305,  United States; Recruiting
District of Columbia
      Organon Investigational Site, Washington,  District of Columbia,  20010,  United States; Recruiting
Massachusetts
      Organon Investigational Site, Boston,  Massachusetts,  02115,  United States; Recruiting
New York
      Organon Investigational Site, New York,  New York,  10021,  United States; Recruiting
Ohio
      Organon Investigational Site, Cleveland,  Ohio,  44195,  United States; Recruiting

Study ID Numbers:  021048
Last Updated:  August 1, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124735
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02