Protocol for Eslax Intravenous Drug Use Investigation (Study P06082) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00902070

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:	Prospective
Official Title:	Protocol for Eslax Intravenous Drug Use Investigation

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Drug Information available for: ORG 9426 Rocuronium

U.S. FDA Resources

Further study details as provided by Organon:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2010
Estimated 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.

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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902070

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Japan
Coordinating Location	Recruiting
Osaka, Japan

Sponsors and Collaborators

Organon

More Information

No publications provided

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	P06082
Study First Received:	May 13, 2009
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00902070 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Neuromuscular Nondepolarizing Agents
Bromides
Rocuronium
Neuromuscular Blocking Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Neuromuscular Nondepolarizing Agents
Rocuronium
Physiological Effects of Drugs
Neuromuscular Agents

Neuromuscular Blocking Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009