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Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

Protocol for Eslax Intravenous Drug Use Investigation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00902070
Enrollment
3969
Registered
2009-05-14
Start date
2007-11-30
Completion date
2010-10-31
Last updated
2015-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

The main purpose of this investigation is to collect safety and efficacy information of Eslax Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as Eslax) in daily clinical settings.

Detailed description

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Interventions

DRUGRocuronium

Normally, for adults, 0.6 mg/kg of rocuronium bromide is intravenously administered to support endotracheal intubation. If additional administration is necessary, 0.1 - 0.2 mg/kg is intravenously administered. In the case of continuous infusion, infusion is initiated at a rate of 7 μg/kg/min. Dosage should be adjusted based on the age or symptom. The upper limit of this drug for the intubation is 0.9 mg/kg.

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation.

Exclusion criteria

* Patients with a history of hypersensitivity to Eslax or bromide. * Patients with myasthenia gravis or myasthenic syndrome.

Design outcomes

Primary

MeasureTime frame
incidence of adverse eventsThe standard observation period for a patient is duration of hospital stay (from one week before Eslax administration to one week after administration at a maximum).

Secondary

MeasureTime frame
intubation scoreFrom administration of Eslax to completion of intubation
intubation completion timeFrom administration of Eslax to completion of intubation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026