- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07597564
Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation
Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation: Prospective Randomized Double-blind Study
This randomized, double-blind, controlled clinical study will evaluate the effects of different dose combinations of intravenous metoprolol and sufentanil on cardiovascular responses during oral endotracheal intubation under general anesthesia.
Endotracheal intubation may cause transient increases in heart rate and blood pressure due to sympathetic stimulation. This study aims to determine whether metoprolol, in combination with different doses of sufentanil, can improve hemodynamic stability during and after intubation.
A total of 900 adult patients aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who are scheduled for elective non-cardiac surgery under general anesthesia with endotracheal intubation will be enrolled. Participants will be randomly assigned to one of 30 groups according to the combination of metoprolol dose and sufentanil dose. Metoprolol doses include 0, 0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg, and sufentanil doses include 0.1, 0.2, 0.3, 0.4, and 0.5 mcg/kg.
All participants will receive standardized anesthetic induction and maintenance. Hemodynamic changes will be observed for 10 minutes after intubation. The main outcome is the success rate of hemodynamic stability within 0 to 10 minutes after intubation. Secondary outcomes include the incidence of hypotension, hypertension, bradycardia, and tachycardia.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yanhua Guo
- Número de teléfono: +86-18050333902
- Correo electrónico: guoyanhua19@126.com
Ubicaciones de estudio
-
-
Fujian
-
Fuzhou, Fujian, Porcelana, 350000
- Fujian Provincial Hospital
-
Contacto:
- Yanhua Guo
- Número de teléfono: +86-18050333902
- Correo electrónico: guoyanhua19@126.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 to 65 years.
- American Society of Anesthesiologists physical status I or II.
- Scheduled for elective non-cardiac surgery.
- Planned general anaesthesia with endotracheal intubation.
Exclusion Criteria:
- Cardiovascular or respiratory diseases, such as uncontrolled hypertension or bronchial asthma.
- Current use of β-blockers.
- History of chronic drug use or alcohol abuse.
- Hepatic or renal impairment.
- Known allergy to any study drug.
- Anticipated difficult airway.
- Any other condition that may affect the conduct of the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Metoprolol 0 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Comparador activo: Metoprolol 0 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Comparador activo: Metoprolol 0 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Comparador activo: Metoprolol 0 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Comparador activo: Metoprolol 0 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Experimental: Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Experimental: Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percentage of participants achieving hemodynamic stability after tracheal intubation
Periodo de tiempo: within 0-10 min after intubation
|
within 0-10 min after intubation
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
incidence of bradycardia
Periodo de tiempo: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of tachycardia
Periodo de tiempo: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of hypotension
Periodo de tiempo: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of hypertension
Periodo de tiempo: within 0-10 min after intubation
|
within 0-10 min after intubation
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
|
adverse event
Periodo de tiempo: up to 24 hours postoperatively
|
up to 24 hours postoperatively
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yanhua Guo, Fujian Provincial Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Términos MeSH relevantes adicionales
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Preparaciones farmacéuticas
- Amina
- Piperidinas
- Soluciones cristaloides
- Soluciones isotónicas
- Soluciones
- Alcoholes
- Fenoxipropanolaminas
- Propanolaminas
- Amino alcoholes
- Propanols
- Fentanilo
- Metoprolol
- Sufentanilo
- Solución salina
Otros números de identificación del estudio
- K2024-03-015/02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .