Comparison of Analgesic Requirements in Patients Receiving Nuss Operation Using 2 Different Anesthetic Adjuvants (ARNRD)
18 de marzo de 2020 actualizado por: Jung Min Koo
Comparing Analgesic Requirements in Patients Receiving Nuss Operation Using Remifentanil or Dexmedetomidine as Anesthetic Adjuvants
Nowadays, general anaesthesia is carried under "balanced anesthesia technique" in which many anesthetic adjuvants are used simultaneously, including opioid analgesics in order to reduce the amount of inhalation agents. The most popular adjuvants used are remifentanil, which is an opioid analgesic, and dexmedetomidine. Both of these agents are short acting, can be infused with targeted concentrations, excreted shortly from the body with stable hemodynamics.
Remifentanil, when infused for more than 2 hours, causes hyperalgesia to increase the amount of pain postoperatively as well as the amount of opioid analgesics. However, dexmedetomidine does not cause hyperalgesia and is known to have an opioid -sparing effect. In our center.
In this study, we aim to compare the effects of remifentanil and dexmedetomidine on postoperative pain in patients undergoing Nuss procedure, which is a very painful operation on the chest wall.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
62
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Seoul, Corea, república de
- Jung Min Koo
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 60 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Adults aged >20
- Patients undergoing Nuss bar operation (pectus excavatum repair surgery)
- American Society of Anesthesiologists classification I ~ III
Exclusion Criteria:
- Drug abuse history
- Chronic pain in need of continuous opioid analgesics administration
- History of psychiatric diseases
- Preoperative bradycardia (heart rate < 50/min) or arrythmia
- Cardiac diseases other than diabetes or hypertension - coronary artery disease, ischemic heart disease
- Moderate liver or kidney dysfunction
- Pregnant or breast feeding women
- Hypersensitivity to the study drugs
- Patients who do not agree to participate
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador falso: Remifentanil group
In both interventional groups, Sevoflurane is used as an inhalational agent, in 0.5-1.5% age-adjusted Minimal Alveolar Concentration (MAC).
As explained above, remifentanil is infused with Target Controlled Infusion pump, and concentration is adjusted so that Bispectral index (BIS) is maintained as 40-60, which means that the patients are maintained in general anesthesia.
Remifentanil is usually infused with the effect site concentration of 2.0 to 6.0 ng/ml during general anesthesia.
If bradycardia or hypotension develops due to remifentanil infusion, the infusion rate could be reduced, or inotropic, vasopressor, anticholinergic agents can be used (ephedrine, atropine, etc.) to correct the side effects of the drug, or the drug infusion can even be ceased.
At the end of the surgery when skin closure starts, remifentanil infusion will be stopped.
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Comparing effects of remifentanil versus dexmedetomidine
Otros nombres:
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Comparador activo: Dexmedetomidine group
In both interventional groups, Sevoflurane is used as an inhalational agent, in 0.5-1.5% age-adjusted MAC (Minimal Alveolar Concentration).
As explained above, dexmedetomidine is infused with syringe pump, and concentration is adjusted so that Bispectral index (BIS) is maintained as 40-60, which means that the patients are maintained in general anesthesia.
Dexmedetomidine is loaded for 10 minutes in 1mcg/kg, and then infusion rate is set between 0.4 to 0.6mcg/kg/hour for this study.
If bradycardia or hypotension develops due to remifentanil infusion, the infusion rate could be reduced, or inotropic, vasopressor, anticholinergic agents can be used (ephedrine, atropine, etc.) to correct the side effects of the drug, or the drug infusion can even be ceased.
At the end of the surgery when skin closure starts, dexmedetomidine infusion will be stopped.
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Comparing effects of remifentanil versus dexmedetomidine
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Visual Analogue Scale
Periodo de tiempo: Between 1~6 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 1~6 hours postoperatively.
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Visual Analogue Scale
Periodo de tiempo: Between 6~12 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 6~12 hours postoperatively.
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Visual Analogue Scale
Periodo de tiempo: Between 12~24 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 12~24 hours postoperatively.
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Visual Analogue Scale
Periodo de tiempo: Between 24~48 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 24~48 hours postoperatively.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Amount of postoperative intravenous patient controlled analgesics (PCA) used
Periodo de tiempo: At 60 minutes after the end of surgery
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At 60 minutes after the end of surgery
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Amount of fentanyl used postoperatively at the recovery unit
Periodo de tiempo: At 60 minutes after the end of surgery
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Amount in micgrograms per wegith in kilograms (migrogram/kilogram)
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At 60 minutes after the end of surgery
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Time needed for postoperative rescue opioid analgesics
Periodo de tiempo: At 60 minutes after the end of surgery
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At 60 minutes after the end of surgery
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Amount of remifentanil or dexmedetomidine used intraoperatively
Periodo de tiempo: Immediately at the end of the surgery
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Immediately at the end of the surgery
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Intraoperative hemodynamic change: Systolic blood pressure
Periodo de tiempo: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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Intraoperative hemodynamic change: Diastolic blood pressure
Periodo de tiempo: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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Intraoperative hemodynamic change: mean blood pressure
Periodo de tiempo: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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Intraoperative hemodynamic change: heart rate
Periodo de tiempo: 30 minutes after the induction of anesthesia
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30 minutes after the induction of anesthesia
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Intraoperative hemodynamic change: mean blood pressure
Periodo de tiempo: At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Intraoperative hemodynamic change: heart rate
Periodo de tiempo: At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Intraoperative hemodynamic change: Systolic blood pressure
Periodo de tiempo: At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Intraoperative hemodynamic change: Diastolic blood pressure
Periodo de tiempo: At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Rescue drugs (inotropics or vasopressors) used in order to correct hypotension or bradycardia
Periodo de tiempo: Intraoperatively
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Intraoperatively
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Postoperative complications
Periodo de tiempo: Between 1~6 hours postoperatively
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Number of events that happened to the patient: e.g.
Yes or No, and how many times.
Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)
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Between 1~6 hours postoperatively
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Postoperative complications
Periodo de tiempo: Between 12~24 hours postoperatively
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Number of events that happened to the patient: e.g.
Yes or No, and how many times.
Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)
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Between 12~24 hours postoperatively
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Postoperative complications
Periodo de tiempo: Between 24~48 hours postoperatively
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Number of events that happened to the patient: e.g.
Yes or No, and how many times.
Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)
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Between 24~48 hours postoperatively
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jung Min Koo, M.D, Data recruitment
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de septiembre de 2019
Finalización primaria (Anticipado)
21 de febrero de 2021
Finalización del estudio (Anticipado)
28 de febrero de 2021
Fechas de registro del estudio
Enviado por primera vez
20 de agosto de 2019
Primero enviado que cumplió con los criterios de control de calidad
27 de agosto de 2019
Publicado por primera vez (Actual)
29 de agosto de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
18 de marzo de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Analgésicos no narcóticos
- Agonistas del receptor adrenérgico alfa-2
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Analgésicos Opiáceos
- Estupefacientes
- Hipnóticos y sedantes
- Remifentanilo
- Dexmedetomidina
Otros números de identificación del estudio
- KC19MCSI0334
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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