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临床试验/NCT07114250
NCT07114250尚未招募不适用

Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Patients Undergoing Supine Percutaneous Nephrolithotomy

Tanta University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Patient satisfaction

研究概览

简要总结

The aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in PCNL operation in supine position.

详细描述

Nephrolithiasis remains a common health problem around the globe. Percutaneous nephrolithotomy is the preferred modality for large and complex renal calculi. Percutaneous nephrolithotomy is the treatment of choice for calculi which fail treatment with extracorporeal shockwave lithotripsy and ureteral endoscopy.

There are variations to Percutaneous nephrolithotomy, including position, imaging modality, dilatation method, and anesthesia method. There is conflicting evidence between the appropriate use of general anesthesia versus spinal anesthesia for Percutaneous nephrolithotomy

The conventional position of Percutaneous nephrolithotomy is prone, which allows direct access to the posterior calyx with minimal risk of bowel puncture.

However, this positioning method limits the possibility of switching anesthesia from regional to general. The alternative position is supine Advantage in this position is that the spine does not overlap with kidney and fluoroscopic visualization can be achieved.

Nowadays, Percutaneous nephrolithotomy is usually performed under general anesthesia from a urological perspective, the particular advantages of general anesthesia in Percutaneous nephrolithotomy procedure include its feasibility to control tidal volume, secure patient airway, and extensibility of anesthesia time. The feasibility of controlling tidal volume minimizes renal mobility secondary to respiration while the extensibility of anesthesia time allows the surgeon to create multiple punctures with subsequently increased efficacy of the procedure . Despite the superior results of Percutaneous nephrolithotomy surgeries under general anesthesia, it has found to be associated with certain disadvantages such as its high cost and higher incidences of drug interactions. The incidence of complications is high especially when the position of patient is changed from supine to prone position. Common complications associated with use of general anesthesia i.e. injury to lung, brachial plexus, tongue and occasionally to spinal cord are its major drawback. Other minor but common side effects include postoperative nausea and vomiting On the other hand, there are recent reports regarding the use of spinal anesthesia in Percutaneous nephrolithotomy demonstrating lower post-operation pain, less drug intake, less bleeding, and reduces venous pressure in the surgery field .A limited number of prospective randomized trials have been carried out to establish which one of these procedures is better at decreasing perioperative complications. The influence of the type of anesthesia on the effectiveness of Percutaneous nephrolithotomy remains uncertain. Thus, the aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in Percutaneous nephrolithotomy operation in supine position.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
22 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age more than 21 years old.
  • •Both sexes.
  • •American Society of Anesthesiologists physical status (I- II).
  • •Patient with single renal stone size 2-3cm prepared for supine Percutaneous nephrolithotomy

排除标准

  • •Patient refusal.
  • •Pregnancy
  • •Morbid obese with Body mass index > 35 kg/m
  • •Contraindication for spinal anesthesia.
  • •Renal anomalies (horseshoe kidney, ectopic kidney).
  • •Presence of multiple stones or staghorn stones.

研究组 & 干预措施

Spinal Anesthesia

Experimental

Spinal Anesthesia: Patients included in this group will undergo supine Percutaneous nephrolithotomy under spinal anesthesia

干预措施: spinal anesthesia (Procedure)

General Anesthesia

Experimental

Patients included in this group will undergo supine Percutaneous nephrolithotomy under general anesthesia.

干预措施: General Anesthesia (Procedure)

结局指标

主要结局

Patient satisfaction

时间窗: 24 hours

Degree of patient satisfaction will be assessed according to a 5-point Likert scale (5: excellent, 4: Good, 3: Satisfactory, 2: Poor, 1: Very poor)

次要结局

  • Visual analog scale(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Ahmed Mahmoud Ibrahim Hamouda

Resident

Tanta University

研究点 (1)

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