Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

Anesthesia Clinical Trial

Official title:

Protocol for Eslax Intravenous Drug Use Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902070
• Other study ID #: P06082
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: October 29, 2015
• Start date: November 2007
• Est. completion date: October 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3969
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of adverse events		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).	Yes
Secondary	intubation score		From administration of Eslax to completion of intubation	Yes
Secondary	intubation completion time		From administration of Eslax to completion of intubation	Yes