- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02582112
Warming IV Fluids and Incidence of Hypotension
Do Warming iv Fluids During the Management of Spinal- Induced Hypotension Decrease the Incidence of Hypotension and Reduce the Requirement of Fluid, Blood and Ephedrine?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Inadvertent perioperative hypothermia during cesarean delivery is not rare and frequently neglected, despite the recommendations by clinical guidelines. Exposure to cold air and infusing non-warmed intravenous (iv) fluids are the other main sources of inadvertent hypothermia. Spinal anesthesia used during the cesarean delivery has also been demonstrated to impair normal autonomic thermoregulatory control and extend inadvertent perioperative hypothermia. Various measures such as pre-warming of patients or fluids before anesthesia, peroperative warming of iv fluids and active/passive cutaneous warming techniques have all been used to prevent or to reduce inadvertent perioperative hypothermia. This prospective, double-blinded, randomized, controlled study was undertaken to evaluate whether warming IV fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine and transfusion requirement and lower fluid consumption than use of room-temperature fluids (22 oC) in cesarean delivery patients undergoing spinal anesthesia.
The hypothesis was that in elective caesarean delivery patients undergoing spinal anesthesia, warming intravenous fluids, would reduce the incidence of hypotension, ephedrine and transfusion requirement and volume consumption. Thus, the primary outcome measure of the present study was the incidence of intraoperative maternal hypotension and ephedrine requirement during spinal anaesthesia for caesarean section. Secondary outcome measures were total volume consumption, blood loss, pain scores, shivering and maternal and foetal side effects.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Adana, Pavo, 01330
- Hakki Unlugenc
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Inclusion criteria were previous cesarean delivery and breech presentation.
Exclusion Criteria:
- Exclusion criteria included parturients younger than 18 and older than 43 years, significant coexisting disease such as preeclampsia or eclampsia, thyroid disorders, neurological disorders, increased risk of intra-operative hemorrhage (such as placenta accreta), and any contraindication to regional anaesthesia such as bleeding disorders or local infection.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Grupo de control
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Placebo Comparator: Control group
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Comparador activo: Warming group
Active Comparator: Warming group
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Placebo Comparator: Control group
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The primary outcome measure of the present study was the incidence of intraoperative maternal hypotension and ephedrine requirement during spinal anaesthesia for caesarean section
Periodo de tiempo: 6 months
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Systolic and diastolic blood pressures (mmHg) and Ephedrine and transfusion requirement (n /mg)
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Secondary outcome measures were total volume consumption.
Periodo de tiempo: 6 months
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Total volume consumption (mL),
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6 months
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Secondary outcome measures were pain scores
Periodo de tiempo: 6 months
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Pain scores (VRS),
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6 months
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Secondary outcome measures were shivering and maternal and foetal side effects.
Periodo de tiempo: 6 months
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side effects such as shivering, nausea, vomiting, bradycardia, hypoxia (y/n)
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Hakkı Ünlügenç, Prof Dr, Cukurova University
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HZLTNS98
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