Hemodynamic Effects of Surgical Position in Prone vs. Supine Percutaneous Nephrolithotomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGaziosmanpasa Research and Education Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA physical status I-III

Presence of renal calculi indicated for PNL

Disqualifiers

Pregnancy

Uncontrolled coagulopathy

Previous renal surgery

Severe cardiac, pulmonary, or neurological disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prone Position Percutaneous Nephrolithotomy

    Procedure/Surgery

    Patients in this arm 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.

  • Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia)

    Procedure/Surgery

    Patients in this arm 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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Prone PositionExperimental treatment 1 intervention
Group B: Supine PositionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hemodynamic Parameters (Intraoperative)

Systolic blood pressure (mmHg) will be recorded at predefined time points (preoperative baseline, intraoperative intervals, and immediate postoperative period) to assess intraoperative hemodynamic stability.

Time frame
From induction of anesthesia to the end of surgery (approximately 60-120 minutes)
2

Change in Arterial Blood pH

Arterial pH will be measured at predefined time points (preoperative, intraoperative, postoperative day 1) to evaluate metabolic changes between prone and supine groups.

Time frame
Preoperative, intraoperative, postoperative day 1
3

Change in Diastolic Blood Pressure (Intraoperative)

Diastolic blood pressure (mmHg) will be recorded at predefined time points (preoperative baseline, intraoperative intervals, and immediate postoperative period) to assess intraoperative hemodynamic stability.

Time frame
From induction of anesthesia to the end of surgery (approximately 60-120 minutes
4

Change in Mean Arterial Pressure (Intraoperative)

Mean arterial pressure (mmHg) will be recorded at predefined time points (preoperative baseline, intraoperative intervals, and immediate postoperative period) to assess intraoperative hemodynamic stability.

Time frame
From induction of anesthesia to the end of surgery (approximately 60-120 minutes)

Secondary outcomes

1

Operative Time

Total time from initial skin incision to completion of stone removal will be recorded for each group.

Time frame
From initial skin incision until completion of stone removal (approximately 30-180 minutes).
2

Anesthesia Duration

Total anesthesia time will be measured to assess any differences related to patient positioning.

Time frame
From induction of anesthesia until termination of anesthesia and awakening of the patient (approximately 60-240 minutes).
3

Intraoperative Blood Loss

Estimated blood loss will be calculated and recorded; intraoperative transfusion requirements will also be noted.

Time frame
Intraoperative period (from skin incision to completion of surgery, approximately 30-180 minutes).
4

Complication Rate

Complications will be identified and classified according to the Clavien-Dindo classification system.

Time frame
From intraoperative period through hospital stay and up to 30 days postoperatively.

Other outcomes

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