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- Ensaio Clínico NCT07664384
General Versus Spinal Anesthesia in RIRS
Comparative Study of General Versus Spinal Anesthesia in Retrograde Intrarenal Surgery: Impact of Stone Size on Perioperative Outcomes
Visão geral do estudo
Status
Condições
Descrição detalhada
Urolithiasis is a common urological condition with a rising global incidence and prevalence, largely attributed to lifestyle, dietary factors, and metabolic disorders. The lifetime risk of developing urinary stones is estimated to be approximately 10-15%, with a high recurrence rate that imposes a significant burden on healthcare systems. Advances in minimally invasive techniques have revolutionized the management of renal calculi, with retrograde intrarenal surgery (RIRS) emerging as a safe and effective modality for treating renal stones of varying sizes and locations.
RIRS, performed using flexible ureteroscopy and laser lithotripsy, has gained widespread acceptance due to its minimally invasive nature, reduced morbidity, and favorable stone-free rates. It is particularly advantageous for managing stones less than 2 cm, although its indications have expanded to include larger and more complex stones in selected cases. Despite these advantages, several factors influence the success and safety of RIRS, including stone size, location, density, surgeon experience, and perioperative management strategies.
Among perioperative factors, the choice of anesthesia plays a critical role in determining surgical conditions and patient outcomes. General anesthesia (GA) is traditionally preferred for RIRS as it provides optimal airway control, complete immobility, and controlled ventilation, thereby facilitating precise endoscopic manipulation. In contrast, spinal anesthesia (SA) has been proposed as an alternative due to its advantages such as reduced postoperative pain, lower incidence of nausea and vomiting, and avoidance of airway-related complications. However, concerns remain regarding its limitations, including patient movement, inadequate control of respiration, and hemodynamic instability.
By evaluating stone-free rates and perioperative complications across different stone size categories, this study seeks to provide evidence-based guidance for optimizing anesthesia selection in RIRS.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Qena Governorate
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Qina, Qena Governorate, Egito, 83511
- Qena University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Adult patients (≥18 years) scheduled for elective RIRS for renal stones <2 cm.
- Written informed consent obtained.
Exclusion Criteria:
- History of previous ureteral surgery or known ureteral stricture.
- Multiple or bilateral renal stones requiring staged procedures.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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General Anesthesia
patients in this group receive general anesthesia for RIRS: Intravenous anesthetic induction, Endotracheal intubation, controlled ventilation, muscle relaxation and inhalational anesthetic maintenance.
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Spinal Anesthesia
patients in this group receive spinal anesthesia for RIRS: Standard spinal block using bupivacaine without sedation.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Stone Free Rate
Prazo: after the first postoperative month.
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Follow-up Ultrasound/Computed Tomography (US/CT) to assess stone-free status after the first postoperative month.
Success was considered as residues of <2mm or absence of any stone fragments.
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after the first postoperative month.
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Total opioid consumption
Prazo: Perioperative
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Total opioid consumption in the whole postoperative period is recorded
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Perioperative
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain assessement
Prazo: at 6 hours, 12 hours, 24 hours
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pain is assessed uing Numerical Rating Scale where patients are asked to select a number from 0 to 10 to quantify their pain level where 0= no pain at all and 10= worst pain imaginable
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at 6 hours, 12 hours, 24 hours
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Patient Satisfaction
Prazo: Perioperative
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patients are asked to evaluate their satisfaction using a simple 4 point likert scale, where 4= Very Satisfied, 3= Satisfied, 2= Dissatisfied, 1= Very Dissatisfied
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Perioperative
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PACU stay
Prazo: Perioperative
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the duration of stay in PACU (postanesthetic care unit) is recorded
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Perioperative
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Outros números de identificação do estudo
- AIP02942673
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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