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Rocuronium bolus maintenance

Phase 3

Anesthesia | Small molecule | Pain |Merck & Company, Inc.|Last Updated: Aug 24, 2016

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment149

FDA Designations

No designations recorded

Clinical trial landscape

Rocuronium bolus maintenance · 1 trial · 1 indication

Phase 3 1
NCT00124735A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)Anesthesia
COMPLETED149 Analytics
PHASE3COMPLETED
A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
AnesthesiaUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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)
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)
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)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rocuronium bolus maintenanceEXPERIMENTALRocuronium bolus maintenance
Rocuronium continuous infusion maintenanceEXPERIMENTALRocuronium continuous infusion maintenance

Interventions

NameTypeDescription
Rocuronium bolus maintenanceDRUGSubjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
rocuronium continuous infusion maintenanceDRUGSubjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
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Eligibility Criteria

Age RangeN/A to 17 Years
SexALL
Healthy VolunteersNo

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) ...

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Competitive Landscape -Anesthesia and Sedation 4 trials (matched to "Anesthesia")

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Frequently asked questions about Rocuronium bolus maintenance

What is Rocuronium bolus maintenance used for?

Rocuronium bolus maintenance is used for anesthesia. It is a small molecule being studied as a maintenance dose of rocuronium during anesthesia. The drug is being developed by Merck & Company, Inc. for use in the therapeutic area of pain, specifically in the context of anesthesia.

Who makes Rocuronium bolus maintenance?

Rocuronium bolus maintenance is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this drug for use in anesthesia. The drug is a small molecule and is currently in Phase 3 clinical development.

What phase is Rocuronium bolus maintenance in?

Rocuronium bolus maintenance is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for use in anesthesia, with one completed Phase 3 trial involving 149 participants.

What clinical trials is Rocuronium bolus maintenance in?

Rocuronium bolus maintenance has one completed clinical trial, NCT00124735, titled 'A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)'. This Phase 3 trial enrolled 149 participants and was a controlled, randomized study in anesthesia.

Is Rocuronium bolus maintenance the same as Zemuron?

Rocuronium bolus maintenance is related to Zemuron, as the clinical trial NCT00124735 refers to rocuronium bromide (Zemuron®). The drug is being studied as a maintenance dose of rocuronium, which is the active ingredient in Zemuron. The trial focused on determining dose requirements in pediatric and adolescent subjects.