- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01688648
Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Lidocaine has been reported to have an antiarrhythmic and myocardial protective effect. A previous study has reported that low-dose lidocaine infusion can decrease the incidence of ventricular fibrillation and tachycardia during the first 24 hours after coronary artery bypass graft (CABG). A recent study also reported that the lidocaine infusion during CABG could decrease the myocardial injury by measuring the CK-MB and Troponin-I blood level.
Dexmedetomidine is an alpha-2 agonist and reduces the sympathetic tone and neuroendocrine stress response. Dexmedetomidine was reported to have a cardioprotective effect by a previous animal study. However, there was no clinical study evaluating the cardioprotective effect of dexmedetomidine.
Therefore, we are trying to evaluate and compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Seoul, Corea, república de, 135-710
- Samsung Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center
Exclusion Criteria:
- Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome
- Patients with recent exogenous steroid administration or previous diuretics therapy
- Patients with recent myocardial infarction
- Those undergoing unplanned cardiopulmonary bypass during the surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Lidocaine group
a bolus dose of lidocaine 1.5 mg/kg after anesthetic induction with following lidocaine infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
|
a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
Otros nombres:
|
Experimental: Dexmedetomidine group
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
|
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
Otros nombres:
|
Experimental: Combined infusion group
Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group
|
a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
Otros nombres:
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
Otros nombres:
|
Sin intervención: Control group
The group without infusion of lidocaine or dexmedetomidine
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Myocardial injury marker
Periodo de tiempo: postoperative ICU day 1
|
Myocardial injury marker - CK-MB, and Troponin(i) blood level
|
postoperative ICU day 1
|
Myocardial injury marker
Periodo de tiempo: postoperative ICU day 2
|
Myocardial injury marker - CK-MB, and Troponin(i) blood level
|
postoperative ICU day 2
|
Myocardial injury marker
Periodo de tiempo: postoperative ICU day 3
|
Myocardial injury marker - CK-MB, and Troponin(i) blood level
|
postoperative ICU day 3
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The blood sodium, potassium, calcium level
Periodo de tiempo: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
|
The blood sodium, potassium, calcium level
|
1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
|
The incidence of arrhythmia during and after the surgery
Periodo de tiempo: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
|
The incidence of arrhythmia during and after the surgery: Ventricular premature beat,Atrial premature complex, Bigeminy, Trigeminy, Atrial fibrillation, Ventricular tachycardia, Ventricular fibrillation, Atrio-Ventricular block, PSVT, Junctional rhythm, External pacing |
1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
|
Postoperative ICU stay, Hospital stay, Extubation time
Periodo de tiempo: 1 day after hospital discharge
|
Postoperative ICU stay, Hospital stay
|
1 day after hospital discharge
|
Inotropics use during and after the surgery
Periodo de tiempo: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
|
Inotropics and other drug use during and after the surgery: Dopamine, NTG, dobutamine, milrinone, epinephrine, norepinephrine, amiodarone, diltiazem, remifentanil, esmolol, labetalol, nicardipine, Lasix, phenylephrine, lidocaine, sufentanil
|
1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
|
The incidence of hypokalemia
Periodo de tiempo: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
|
The incidence of hypokalemia
|
1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Dolor
- Manifestaciones neurológicas
- Dolor de pecho
- Angina de pecho
- Arritmias Cardiacas
- Angina Inestable
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes antiarrítmicos
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Anestésicos
- Analgésicos no narcóticos
- Agonistas del receptor adrenérgico alfa-2
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Moduladores de transporte de membrana
- Hipnóticos y sedantes
- Anestésicos Locales
- Bloqueadores de canales de sodio activados por voltaje
- Bloqueadores de canales de sodio
- Dexmedetomidina
- Lidocaína
Otros números de identificación del estudio
- 2012-07-098-001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Lidocaine infusion
-
Fondazione Italiana Sindromi Mielodisplastiche-ETSCentro di Riferimento per l'Epidemiologia e la Prev. Oncologica PiemonteTerminado
-
University of PecsMedical University of PecsTerminado