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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Protocol for Eslax Intravenous Drug Use Investigation|
- 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). ] [ Designated as safety issue: Yes ]
- intubation score [ Time Frame: From administration of Eslax to completion of intubation ] [ Designated as safety issue: Yes ]
- intubation completion time [ Time Frame: From administration of Eslax to completion of intubation ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation
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 Name: Eslax
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.