A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia (Study 021049)(COMPLETED)(P05798)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00124722
First received: July 26, 2005
Last updated: October 2, 2009
Last verified: October 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Anesthesia |
Drug: Rocuronium bromide (Zemuron) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 207 |
| Study Start Date: | December 2004 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
|
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
|
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00124722 History of Changes |
| Other Study ID Numbers: | 021049, P05798 |
| Study First Received: | July 26, 2005 |
| Last Updated: | October 2, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Anesthetics Bromides Rocuronium Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Anticonvulsants Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013