Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00902070
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : October 30, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Anesthesia Drug: Rocuronium

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.

Study Type : Observational
Actual Enrollment : 3969 participants
Time Perspective: Prospective
Official Title: Protocol for Eslax Intravenous Drug Use Investigation
Study Start Date : November 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation
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.
Other Name: Eslax

Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. intubation score [ Time Frame: From administration of Eslax to completion of intubation ]
  2. intubation completion time [ Time Frame: From administration of Eslax to completion of intubation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japanese 3000 patients

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.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00902070     History of Changes
Other Study ID Numbers: P06082
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs