Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)
- Registration Number
- NCT00902070
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3969
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Rocuronium Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method intubation score From administration of Eslax to completion of intubation intubation completion time From administration of Eslax to completion of intubation