Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

NCT00902070 | Completed

• 1 other identifier: P06082
• Study Type: observational
• Target: 3,969
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (2)

• intubation score

  From administration of Eslax to completion of intubation

• intubation completion time

  From administration of Eslax to completion of intubation

Study Arms (1)

1

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

Drug: Rocuronium

Interventions

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.

Also known as: Eslax

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Japanese 3000 patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: November 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 30, 2015

Record last verified: 2015-10