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Rocuronium bolus maintenance

Phase 3FDA approved

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

Rocuronium bolus maintenance development status

FDA approval on record Aug 28, 2008 as Zemuron
Approval holderOrganon Usa Inc
ApplicationNDA020214
Highest phase Phase 3
Registered trials 2 across 1 sponsor since Jul 2005

Rocuronium bolus maintenance target and mechanism

Molecular targetCHRNA1, CHRNG, CHRNB1, CHRND, CHRNE
Target classAntagonist
ModalitySmall molecule

Also known as Zemuron, ORG 9426

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment149

FDA Designations

No designations recorded

Rocuronium bolus maintenance clinical trials

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 5 trials (matched to "Anesthesia")

No competing companies are currently tracked in active development for Anesthesia and Sedation.
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Frequently asked questions about Rocuronium bolus maintenance

What is rocuronium bolus maintenance used for?

Rocuronium bolus maintenance is used to sustain muscle relaxation during anesthesia. It is a small molecule neuromuscular blocking agent given as repeated bolus doses to maintain the paralysis established by an initial dose, supporting procedures such as intubation and surgery in pediatric and adolescent patients.

What does rocuronium bolus maintenance target?

Rocuronium bolus maintenance targets nicotinic acetylcholine receptors at the neuromuscular junction, specifically the CHRNA1, CHRNG, CHRNB1, CHRND, and CHRNE subunits. It acts as an antagonist at these receptors, blocking acetylcholine signaling and producing skeletal muscle relaxation during anesthesia.

Who makes rocuronium bolus maintenance?

Rocuronium bolus maintenance is developed by Merck & Company, Inc., which trades under the ticker MRK. The product is associated with the brand name Zemuron.

What phase is rocuronium bolus maintenance in?

Rocuronium bolus maintenance has been studied in Phase 3 clinical development. It is an investigational use of rocuronium bromide for maintaining neuromuscular blockade, and the Phase 3 trial evaluating dose requirements in pediatric and adolescent subjects has been completed.

What clinical trials is rocuronium bolus maintenance in?

Rocuronium bolus maintenance was evaluated in the Phase 3 trial NCT00124735, titled a study to determine the dose requirements of rocuronium bromide (Zemuron) in pediatric and adolescent subjects. That trial enrolled 149 participants, was randomized and controlled, and is now completed.

Is rocuronium bolus maintenance the same as Zemuron?

Yes. Rocuronium bolus maintenance refers to the bolus dosing of rocuronium bromide, which is marketed under the brand name Zemuron. The Phase 3 trial NCT00124735 used the Zemuron name when studying dose requirements in pediatric and adolescent subjects.