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

Phase 3

Completed

• Conditions: Anesthesia
• Interventions: Drug: rocuronium continuous infusion maintenance; Drug: Rocuronium bolus maintenance

• Registration Number: NCT00124735
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-07-26
• Study First Submitted QC: 2005-07-26
• Study First Posted: 2005-07-28
• Primary Completion: 2007-08
• Study Completion: 2007-09
• Results First Submitted: 2008-12-05
• Results First Submitted QC: 2009-03-12
• Results First Posted: 2009-04-15
• Status Verified: 2016-06
• Last Update Submitted: 2016-07-14
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocuronium continuous infusion maintenance	rocuronium continuous infusion maintenance	Rocuronium continuous infusion maintenance
Rocuronium bolus maintenance	Rocuronium bolus maintenance	Rocuronium bolus maintenance

Primary Outcome Measures

Name	Time	Method
Total Dose of Zemuron (Rocuronium) Administered	during surgery	Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four \[TOF\] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol \[PP\] data set)

Secondary Outcome Measures

Name	Time	Method
Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%	after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)	The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%	after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)	The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%	after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)	The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).