- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Qena Governorate
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Qina, Qena Governorate, 이집트, 83511
- Qena University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Stone Free Rate
기간: 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
기간: Perioperative
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Total opioid consumption in the whole postoperative period is recorded
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Perioperative
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain assessement
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .