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A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia

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ClinicalTrials.gov Identifier: NCT00124722
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) in term neonates (birth to <28 days old), infants (28 days to <=3 months) and toddlers (>3 months to <=2 years), 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).

Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.


Condition or disease Intervention/treatment Phase
Anesthesia Drug: Rocuronium bromide (Zemuron) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Assessor-blind, Dose-ranging, Phase IIIB, Multicenter Trial Comparing the Intubating Conditions and Time Course of Block of Three Different Intubating Doses (0.45 mg/kg, 0.6 mg/kg, and 1.0 mg/kg) of Zemuron® in Pediatric and Adolescent Subjects Under General Anesthesia
Study Start Date : December 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 0.45 mg/kg Zemuron
0.45 mg/kg Zemuron
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.
Other Names:
  • ORG 9426
  • SCH 900085
  • Zemuron
Active Comparator: 0.6 mg/kg Zemuron
0.6 mg/kg Zemuron
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.
Other Names:
  • ORG 9426
  • SCH 900085
  • Zemuron
Experimental: 1.0 mg/kg Zemuron
1.0 mg/kg Zemuron
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.
Other Name: ORG 9426, SCH 900085, Zemuron



Primary Outcome Measures :
  1. Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation) [ Time Frame: during surgery ]

Secondary Outcome Measures :
  1. Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score [ Time Frame: during and after surgery ]


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia.

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 trial will not be allowed to enter.

Publications of Results:
Tirotta CF, Brandom B, Siddiqui MS, Ehlers M, Betzel J, Chen J-Y, De Bie J, Blobner M. Time Course of Rocuronium-Induced Neuromuscular Blockade in Pediatric Patients: A Phase III, Randomized, Dose-Response Study. J Anesthe Clin Res. 2012;3:189.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00124722     History of Changes
Other Study ID Numbers: P05798
021049
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Rocuronium
Bromides
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants