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

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

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).

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Rocuronium bolus maintenance; Drug: rocuronium continuous infusion maintenance

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rocuronium bolus maintenance	Drug: Rocuronium bolus maintenance; Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation; Other Names: Zemuron; ORG 9426
Experimental: Rocuronium continuous infusion maintenance	Drug: rocuronium continuous infusion maintenance; Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation; Other Names: Zemuron; ORG 9426

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Dose of Zemuron (Rocuronium) Administered	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)	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%	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%).	after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%	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%).	after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%	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%).	after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Bhattacharya ST, Jeffrey Koh J, Martin L, Suresh S, Frietsch T. Randomized, Multicenter Trial of Rocuronium in Neonates, Infants, Toddlers, Children & Adolescents [abstract]. Anesthesiology. 2009;111(5):A841.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: July 26, 2005
• First Submitted That Met QC Criteria: July 26, 2005
• First Posted (Estimate): July 28, 2005

Study Record Updates

• Last Update Posted (Estimate): August 24, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: P05797; 21048