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- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Muhammad M Abbas, FCPS
- Número de telefone: 02199215718
- E-mail: smabbas69@hotmail.com
Locais de estudo
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-
Sindh
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Karachi, Sindh, Paquistão, 74200
- Recrutamento
- Sindh Institute of Urology and Transplantation
-
Contato:
- Muhammad M Abbas, FCPS
- Número de telefone: +923331318838
- E-mail: smabbas69@hotmail.com
-
Subinvestigador:
- Love Khatri, IMM
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Thirst intensity upon PACU arrival
Prazo: Up to 2 hours during immediate post-operative period
|
Patients will be asked Did you experience thirst upon arrival in the PACU?
|
Up to 2 hours during immediate post-operative period
|
|
Thirst intensity at PACU discharge
Prazo: Up to 2 hours during immediate post-operative period
|
Patients will be asked Did you experience thirst at PACU discharge?
|
Up to 2 hours during immediate post-operative period
|
|
Patient comfort
Prazo: Up to 2 hours during immediate post-operative period
|
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
|
|
Patient satisfaction with the hydration timing.
Prazo: Up to 2 hours during immediate post-operative period
|
How satisfied are you with the hydration timing? (5-point Likert Scale):
|
Up to 2 hours during immediate post-operative period
|
|
Patient satisfaction with the hydration procedure.
Prazo: Up to 2 hours during immediate post-operative period
|
How satisfied are you with the hydration process overall? (5-point Likert Scale):
|
Up to 2 hours during immediate post-operative period
|
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Total oral water intake (mL) during PACU stay.
Prazo: Up to 2 hours iduring immediate post-operative period
|
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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adverse Events
Prazo: Up to 2 hours during immediate post-operative period
|
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
Prazo: Up to 2 hours during immediate post-operative period
|
Is medical intervention given for any adverse event?
|
Up to 2 hours during immediate post-operative period
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Muhammad M Abbas, FCPS, Sindh Institute of Urology and Transplantation
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SIUT-ERC-2025/A-586
Informações sobre medicamentos e dispositivos, documentos de estudo
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