Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

NCT ID: NCT00902070

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3969 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

Rocuronium

Intervention Type 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.

Interventions

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Rocuronium

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.

Intervention Type DRUG

Other Intervention Names

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Eslax

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P06082

Identifier Type: -

Identifier Source: org_study_id

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