- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07563530
Early Oral Hydration in Relieving Postoperative Thirst
Effectiveness of Early Oral Hydration in Relieving Postoperative Thirst in Patients Undergoing Urological Endoscopic Procedures: A Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Muhammad M Abbas, FCPS
- Número de teléfono: 02199215718
- Correo electrónico: smabbas69@hotmail.com
Ubicaciones de estudio
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Sindh
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Karachi, Sindh, Pakistán, 74200
- Reclutamiento
- Sindh Institute of Urology and Transplantation
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Contacto:
- Muhammad M Abbas, FCPS
- Número de teléfono: +923331318838
- Correo electrónico: smabbas69@hotmail.com
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Sub-Investigador:
- Love Khatri, IMM
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Male and female patients aged 18-65 years.
- Scheduled for elective urological endoscopic procedures under general anesthesia.
- Day-care endoscopic procedures.
- ASA classification I-III.
Exclusion Criteria:
- Known gastrointestinal disorders contraindicating early oral hydration (e.g., peptic ulcer disease, hiatal hernia, irritable bowel syndrome, esophagitis, or prior gastrointestinal surgery).
- Inability to express thirst or communicate (e.g., language barrier, altered consciousness).
- Requirement for nasogastric suction.
- History of facial, oropharyngeal, or laryngeal surgery.
- Swallowing dysfunction or delayed gastric emptying (e.g., gastroparesis).
- Incomplete reversal of muscle relaxant at PACU admission (no adequate spontaneous breathing or protective airway reflexes).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: EOH Group (Early Oral Hydration)
Patients in the intervention group will be allowed early oral hydration on demand upon admission to the PACU if they meet the following safety criteria. Practical PACU checklist to be fulfilled before giving plain water. Require all of the following before any oral intake (start with small sips, e.g., 10 ml): |
"Early oral hydration" refers to the administration of small sips of water (maximum 10 mL initially) within 15-30 minutes of arrival in the PACU, once the patient is fully conscious, stable, and meets safety criteria. Initially, patients will be provided a maximum of 10 mL of water using a straw. After this initial intake, they will be allowed to drink water according to their demand, provided their condition remains stable. To minimize the risk of adverse events such as regurgitation and aspiration, the total amount of water intake will be restricted to 0.5 mL/kg. |
|
Comparador activo: Control Group (Standard PACU Protocol)
Patients in the control group will follow the standard PACU protocol, which will delay oral hydration for 2-3 hours after the end of anesthesia.
During this period, patients will be monitored closely for thirst and other postoperative symptoms.
|
Patients in the control group will follow the standard PACU protocol, which will delay oral hydration for 2-3 hours after the end of anesthesia.
During this period, patients will be monitored closely for thirst and other postoperative symptoms.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Thirst intensity upon PACU arrival
Periodo de tiempo: Up to 2 hours during immediate post-operative period
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Patients will be asked Did you experience thirst upon arrival in the PACU?
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Up to 2 hours during immediate post-operative period
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Thirst intensity at PACU discharge
Periodo de tiempo: Up to 2 hours during immediate post-operative period
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Patients will be asked Did you experience thirst at PACU discharge?
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Up to 2 hours during immediate post-operative period
|
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Patient comfort
Periodo de tiempo: Up to 2 hours during immediate post-operative period
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Rate your comfort level during the PACU stay using the VAS (0-10) (0 = Uncomfortable, 10 = Very comfortable) [0---1---2---3---4---5---6---7---8---9---10] |
Up to 2 hours during immediate post-operative period
|
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Patient satisfaction with the hydration timing.
Periodo de tiempo: Up to 2 hours during immediate post-operative period
|
How satisfied are you with the hydration timing? (5-point Likert Scale):
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Up to 2 hours during immediate post-operative period
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Patient satisfaction with the hydration procedure.
Periodo de tiempo: Up to 2 hours during immediate post-operative period
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How satisfied are you with the hydration process overall? (5-point Likert Scale):
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Up to 2 hours during immediate post-operative period
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Total oral water intake (mL) during PACU stay.
Periodo de tiempo: Up to 2 hours iduring immediate post-operative period
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The total amount of water intake will be restricted to 0.5 mL/kg. The water will be provided in a graduated cup, and the total water intake will be calculated as follows: Total Water Intake (mL) = Volume of water in the cup upon PACU admission - Volume of water remaining in the cup upon PACU discharge. |
Up to 2 hours iduring immediate post-operative period
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adverse Events
Periodo de tiempo: Up to 2 hours during immediate post-operative period
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Do you experience any of the following adverse events after drinking water? (Check all that apply):
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Up to 2 hours during immediate post-operative period
|
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Medical intervention given for any adverse event
Periodo de tiempo: Up to 2 hours during immediate post-operative period
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Is medical intervention given for any adverse event?
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Up to 2 hours during immediate post-operative period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Muhammad M Abbas, FCPS, Sindh Institute of Urology and Transplantation
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SIUT-ERC-2025/A-586
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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