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- Ensayo clínico NCT00379613
Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)
A Multi-Center Randomized Safety Assessor-Blinded Placebo-Controlled Parallel and Dose Escalating Dose-Finding Trial in Subjects of ASA 1 - 2 to Assess the Safety, Efficacy and PK of Sugammadex Administered at 5 Min. After Administration of 1.2 mg/kg Esmeron
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- ASA 1 - 2 between the ages of 18 and 64, inclusive
- Scheduled for surgical procedures with an anticipated duration of anesthesia of at least 90 minutes, without further need for muscle relaxation other than for intubation
- Scheduled for surgery in supine position
- Given written informed consent
Exclusion Criteria:
- Subjects in whom a difficult intubation because of anatomical malformations was expected
- Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction
- Subjects known or suspected to have a (family) history of malignant hyperthermia
- Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- Subjects receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants and Mg2+
- Subjects who had already participated in CT 19.4.205
- Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.205
- Female subjects who are pregnant: in females pregnancy was to be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who were not of childbearing potential i.e. at least 2 years postmenopausal or underwent tubal ligation or an hysterectomy
- Females of childbearing potential not using an acceptable method of birth control: condom or diaphragm with spermicide, vasectomized partner (>6 months), IUD, abstinence
- Subjects giving breast-feeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: 1
rocuronium + 16.0 mg/kg Org 25969
|
After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered |
Experimental: 2
rocuronium + 2.0 mg/kg Org 25969
|
After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered
Otros nombres:
|
Experimental: 3
rocuronium + 4.0 mg/kg Org 25969
|
After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered
Otros nombres:
|
Experimental: 4
rocuronium + 8.0 mg/kg Org 25969
|
After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered
Otros nombres:
|
Experimental: 5
rocuronium + 12.0 mg/kg Org 25969
|
After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9.
Periodo de tiempo: After administration of rocuronium
|
After administration of rocuronium
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7; Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8.
Periodo de tiempo: After administration of rocuronium
|
After administration of rocuronium
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- P05942
- 19.4.205
Plan de datos de participantes individuales (IPD)
Datos del estudio/Documentos
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