The Effect of Surgical Position on Hemodynamics in Percutaneous Nephrolithotomy Performed in Prone and Supine Positions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Hemodynamic Parameters (Intraoperative)
研究概览
简要总结
This prospective, randomized controlled study evaluates the hemodynamic effects of prone and supine positions during percutaneous nephrolithotomy (PNL) for large kidney stones. Surgical position may influence intraoperative and postoperative hemodynamic stability. Prone positioning can increase intrathoracic pressure and reduce venous return, whereas supine positioning may provide greater hemodynamic stability. A total of 84 patients will be randomized to undergo PNL in prone or supine positions. Primary outcomes include changes in hemodynamic parameters during surgery. Results may guide surgical position selection, especially in patients with potential hemodynamic risk.
详细描述
Percutaneous nephrolithotomy (PNL) is a widely used minimally invasive surgical technique for the treatment of large and complex renal calculi. Traditionally, PNL has been performed in the prone position; however, the supine position has gained popularity in recent years due to potential anesthetic and surgical advantages. Surgical positioning can significantly influence cardiovascular and respiratory function, potentially leading to intraoperative and postoperative hemodynamic fluctuations.
Previous literature suggests that the prone position may increase intrathoracic pressure and impair venous return, potentially compromising hemodynamic stability, while the supine position may provide a more stable cardiovascular profile. However, existing data are limited, and results remain inconclusive, particularly in direct comparative studies.
This prospective, randomized controlled clinical trial aims to compare the effects of prone and supine positions during PNL on patients' intraoperative and postoperative hemodynamic parameters. The study will enroll 84 patients aged 18-80 years with American Society of Anesthesiologists (ASA) physical status I-III undergoing elective PNL. Patients will be randomly assigned to either the prone (n=42) or supine (n=42) position.
Inclusion criteria include patients with renal calculi suitable for PNL and meeting the study's eligibility requirements. Exclusion criteria include pregnancy, uncontrolled coagulopathy, previous renal surgery, severe cardiac, pulmonary, or neurological disease, preoperative urinary tract infection, surgery duration outside 60-120 minutes, and multiple access tracts.
Preoperative evaluation will include demographic data, stone characteristics, and relevant laboratory and imaging findings. Intraoperative data will include systolic and diastolic blood pressure, heart rate, arterial blood gas analysis, operative time, anesthesia duration, access details, irrigation volume, and any transfusion or complications. Postoperative parameters will include nephrostomy duration, length of hospital stay, and presence of residual stones as assessed by postoperative CT scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III
- •Presence of renal calculi indicated for PNL
排除标准
- •Pregnancy
- •Uncontrolled coagulopathy
- •Previous renal surgery
- •Severe cardiac, pulmonary, or neurological disease
- •Preoperative urinary tract infection (non-sterile urine culture)
- •Surgery duration <60 minutes or >120 minutes
- •Preoperative blood transfusion
- •Multiple access tracts
研究组 & 干预措施
Prone Position
Patients in this group will undergo percutaneous nephrolithotomy (PNL) in the prone position. The procedure begins with ureteral catheter placement in lithotomy position, followed by prone positioning for renal access under C-arm fluoroscopic guidance. Stone fragmentation will be performed using pneumatic or ultrasonic lithotripters, and nephrostomy placement will be completed according to standard protocol.
干预措施: Prone Position Percutaneous Nephrolithotomy (Procedure)
Supine Position
Patients in this group will undergo percutaneous nephrolithotomy (PNL) in the Galdakao-modified Valdivia supine position. Following general anesthesia, the ipsilateral side will be elevated 20-30°, with the ipsilateral leg extended and the contralateral leg abducted. Ureteral catheter placement will be followed by renal access under C-arm fluoroscopy. Stone fragmentation and removal will be performed using the same standardized lithotripsy and irrigation protocols as in the prone group.
干预措施: Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia) (Procedure)
结局指标
主要结局
Change in Hemodynamic Parameters (Intraoperative)
时间窗: From induction of anesthesia to the end of surgery (approximately 60-120 minutes)
Systolic blood pressure (mmHg) will be recorded at predefined time points (preoperative baseline, intraoperative intervals, and immediate postoperative period) to assess intraoperative hemodynamic stability.
Change in Arterial Blood pH
时间窗: Preoperative, intraoperative, postoperative day 1
Arterial pH will be measured at predefined time points (preoperative, intraoperative, postoperative day 1) to evaluate metabolic changes between prone and supine groups.
Change in Oxygen Saturation
时间窗: Preoperative, intraoperative, postoperative day 1
Arterial oxygen saturation (%) will be measured at predefined time points (preoperative, intraoperative, postoperative day 1) to evaluate respiratory status.
Change in Diastolic Blood Pressure (Intraoperative)
时间窗: From induction of anesthesia to the end of surgery (approximately 60-120 minutes
Diastolic blood pressure (mmHg) will be recorded at predefined time points (preoperative baseline, intraoperative intervals, and immediate postoperative period) to assess intraoperative hemodynamic stability.
Change in Mean Arterial Pressure (Intraoperative)
时间窗: From induction of anesthesia to the end of surgery (approximately 60-120 minutes)
Mean arterial pressure (mmHg) will be recorded at predefined time points (preoperative baseline, intraoperative intervals, and immediate postoperative period) to assess intraoperative hemodynamic stability.
Change in Heart Rate (Intraoperative)
时间窗: From induction of anesthesia to the end of surgery (approximately 60-120 minutes)
Heart rate (beats per minute) will be recorded at predefined time points (preoperative baseline, intraoperative intervals, and immediate postoperative period) to assess intraoperative hemodynamic stability.
Change in Arterial pO₂
时间窗: Preoperative, intraoperative, postoperative day 1
Arterial oxygen partial pressure (mmHg) will be measured at predefined time points (preoperative, intraoperative, postoperative day 1) to evaluate respiratory function.
Change in Arterial HCO₃-
时间窗: Preoperative, intraoperative, postoperative day 1
Arterial bicarbonate (mmol/L) will be measured at predefined time points (preoperative, intraoperative, postoperative day 1) to evaluate metabolic changes.
Change in Arterial pCO₂
时间窗: Preoperative, intraoperative, postoperative day 1
Arterial carbon dioxide partial pressure (mmHg) will be measured at predefined time points (preoperative, intraoperative, postoperative day 1) to evaluate respiratory changes.
次要结局
- Complication Rate(From intraoperative period through hospital stay and up to 30 days postoperatively.)
- Residual Stone Rate(At postoperative 1 month, assessed by CT scan.)
- Length of Hospital Stay(From hospital admission until discharge (typically 2-10 days).)
- Nephrostomy Tube Duration(From postoperative day 0 (day of surgery) until nephrostomy tube removal, typically within 7-14 days.)
- Operative Time(From initial skin incision until completion of stone removal (approximately 30-180 minutes).)
- Anesthesia Duration(From induction of anesthesia until termination of anesthesia and awakening of the patient (approximately 60-240 minutes).)
- Intraoperative Blood Loss(Intraoperative period (from skin incision to completion of surgery, approximately 30-180 minutes).)
研究者
Arif Burak Keçebaş
UROLOGY DOCTOR
Gaziosmanpasa Research and Education Hospital