Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

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.

Completed

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Key information

Conditions

Anesthesia

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rocuronium

Drug

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.

Other names: Eslax

Primary outcomes

incidence of adverse events

Time frame: The 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 outcomes

intubation score

Time frame: From administration of Eslax to completion of intubation
intubation completion time

Time frame: From administration of Eslax to completion of intubation

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Protocol for Eslax Intravenous Drug Use Investigation

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: May 14, 2009
Registry last updated: Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed