Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00902070
First received: May 13, 2009
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention
Anesthesia
Drug: Rocuronium

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Protocol for Eslax Intravenous Drug Use Investigation

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3969
Study Start Date: November 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Japanese 3000 patients

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00902070     History of Changes
Other Study ID Numbers: P06082
Study First Received: May 13, 2009
Last Updated: October 24, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on August 28, 2014