- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03376308
Evaluation of the Effect of Venous Diameter Measurement by Ultrasonography on Pain and Withdrawal Response (VDIAMETER)
During general anesthesia, intravenous (IV) medications can disrupt the patient's comfort by causing a pain sensation or a withdrawal response in the heart. Propofol and rocuronium are among the most common causes of this condition.
In recent years, the use of ultrasonography (USG) in anesthesia has become widespread with the rapid advancement of technology. The use of the patient's head is a non invasive method.
This study is aimed to evaluate whether the size of the venous diameter assessed by ultrasonography in our study is an effect on pain and withdrawal response after drug injections.
Descripción general del estudio
Estado
Descripción detallada
The study was conducted in patients who underwent surgical procedures under general anesthesia by obtaining consent from the Adnan Menderes University Medical Faculty Ethics Board and written consent from the patients and then being admitted to the ASA I-II age group 18-70 years of age.
Patients with peripheric vascular disease, vasculitis, rheumatologic disease, non-cooperative, under the age of 18 and over 70, ASA III and above, allergic to general anesthetic agents and refusing to participate in the study were excluded from the study.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Aydın, Pavo, 09100
- Adnan Menderes University Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
18- 70 years of ASA (American society of anesthesiology) physical status I- II who were to undergo various elective operations
Exclusion Criteria:
Rheumatologic disease Peripheric vascular disease Vasculitis Patients with chronic pain syndrome, Patients with neurologic deficits, Patients with thrombophlebitis, Patients with difficult venous access, Patients with allergy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Caso cruzado
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Group 1
Venous diameter measurements were made via the USG in the hand dorsum. Transverse venous diameter ≤2mm was defined group 1. Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded. |
Four poin scala 0=No Pain
Withdrawal movements
Hemodynamic data were recorded in the patients taken in the operation room.
(T0).
Hemodynamic values (T1) measured 1 minute after administration of intravenous propofol were recorded.
Hemodynamic values (T2) measured 1 minute after administration of intravenous rocuronium were recorded.
Hemodynamic values (T3) measured 1 minute after administration of endotracheal intubation were recorded.
|
Group 2
Venous diameter measurements were made via the USG in the hand dorsum.Transverse venous diameter >2mm was defined group 2.Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded. |
Four poin scala 0=No Pain
Withdrawal movements
Hemodynamic data were recorded in the patients taken in the operation room.
(T0).
Hemodynamic values (T1) measured 1 minute after administration of intravenous propofol were recorded.
Hemodynamic values (T2) measured 1 minute after administration of intravenous rocuronium were recorded.
Hemodynamic values (T3) measured 1 minute after administration of endotracheal intubation were recorded.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The injection pain due to propofol
Periodo de tiempo: 6 month
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Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).
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6 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The withdrawal movement due to rocuronium
Periodo de tiempo: 6 month
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Withdrawal movements are scored as follows: (a) no movement response, (b) movement limited to the wrist, (c)movement limited to the elbow/shoulder, or (d) generalized movement response.
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6 month
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Colaboradores e Investigadores
Patrocinador
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 (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
Palabras clave
Otros números de identificación del estudio
- VASCULAR DIAMETER
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. .
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