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A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron�) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anesthesia

Intervention: Rocuronium bolus maintenance (Drug); rocuronium continuous infusion maintenance (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

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 (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).

Clinical Details

Official title: An Open-label, Randomized, Phase IIIB, Multicenter Trial to Evaluate the Pharmacodynamic Parameters of Intubation Bolus, and Bolus and Infusion Maintenance Doses of Zemuron in Pediatric and Adolescent Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Total Dose of Zemuron (Rocuronium) Administered

Secondary outcome:

Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%

Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%

Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%

Eligibility

Minimum age: N/A. Maximum age: 17 Years. Gender(s): 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.

Locations and Contacts

Additional Information

Starting date: October 2004
Last updated: February 13, 2015

Page last updated: August 23, 2015

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