- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Qena Governorate
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Qina, Qena Governorate, Egypte, 83511
- Qena University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Stone Free Rate
Délai: 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
Délai: Perioperative
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Total opioid consumption in the whole postoperative period is recorded
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Perioperative
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain assessement
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- AIP02942673
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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