Percutaneous Nephrolithotomy (PCNL)NCT07138872
Hemodynamic Effects of Surgical Position in Prone vs. Supine Percutaneous Nephrolithotomy
A study testing Prone Position Percutaneous Nephrolithotomy and Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia) in people with Percutaneous Nephrolithotomy (PCNL) and Surgical Positioning, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Nephrolithotomy (PCNL), Surgical Positioning, Prone Position
- What is being tested?
- Prone Position Percutaneous Nephrolithotomy and Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III
- Presence of renal calculi indicated for PNL
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa Training and Research Hospital
Istanbul, 34275
Arif burak keçebaş, doctor, +90 5412659978, arifkecebas@gmail.com
About this study
Official title: The Effect of Surgical Position on Hemodynamics in Percutaneous Nephrolithotomy Performed in Prone and Supine Positions
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.
Read the detailed description
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.
Surgical techniques will be standardized for both positions. Prone PNL will involve initial lithotomy positioning for ureteral catheter placement followed by prone positioning for renal access under fluoroscopic guidance. Supine PNL will be performed in the Galdakao-modified Valdivia position with similar access and fragmentation protocols.
The primary outcome is the difference in intraoperative and postoperative hemodynamic stability between positions. Secondary outcomes include complication rates, residual stone rates, and hospital stay duration.
This study aims to provide high-quality evidence to guide surgeons and anesthesiologists in selecting the optimal patient position for PNL, particularly in individuals with higher hemodynamic risk.
- Conditions
- Percutaneous Nephrolithotomy (PCNL), Surgical Positioning, Prone Position, Supine Position, Hemodynamic Stability, Nephrolithiasis
- Being tested
- Prone Position Percutaneous Nephrolithotomy, Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia)
- Keywords
- PCNL, Prone Position, Percutaneous Nephrolithotomy, Supine Position, Hemodynamic stability, Nephrolithiasis
- Medical subject headings
- Deception, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone Position Percutaneous NephrolithotomyProcedure or 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 or 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.
| Study group | Role | What they receive |
|---|---|---|
| Prone Position | Experimental | 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. Receives: Procedure: Prone Position Percutaneous Nephrolithotomy |
| Supine Position | Experimental | 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. Receives: Procedure: Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From induction of anesthesia to the end of surgery (approximately 60-120 minutes)
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.
Measured: Preoperative, intraoperative, postoperative day 1
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.
Measured: From induction of anesthesia to the end of surgery (approximately 60-120 minutes
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.
Measured: From induction of anesthesia to the end of surgery (approximately 60-120 minutes)
Change in Heart Rate (Intraoperative)
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.
Measured: From induction of anesthesia to the end of surgery (approximately 60-120 minutes)
Change in Arterial pO₂
Arterial oxygen partial pressure (mmHg) will be measured at predefined time points (preoperative, intraoperative, postoperative day 1) to evaluate respiratory function.
Measured: Preoperative, intraoperative, postoperative day 1
Change in Arterial HCO₃-
Arterial bicarbonate (mmol/L) will be measured at predefined time points (preoperative, intraoperative, postoperative day 1) to evaluate metabolic changes.
Measured: Preoperative, intraoperative, postoperative day 1
Change in Oxygen Saturation
Arterial oxygen saturation (%) will be measured at predefined time points (preoperative, intraoperative, postoperative day 1) to evaluate respiratory status.
Measured: Preoperative, intraoperative, postoperative day 1
Change in Arterial pCO₂
Arterial carbon dioxide partial pressure (mmHg) will be measured at predefined time points (preoperative, intraoperative, postoperative day 1) to evaluate respiratory changes.
Measured: Preoperative, intraoperative, postoperative day 1
Secondary outcomes (7)
Operative Time
Total time from initial skin incision to completion of stone removal will be recorded for each group.
Measured: From initial skin incision until completion of stone removal (approximately 30-180 minutes).
Anesthesia Duration
Total anesthesia time will be measured to assess any differences related to patient positioning.
Measured: From induction of anesthesia until termination of anesthesia and awakening of the patient (approximately 60-240 minutes).
Intraoperative Blood Loss
Estimated blood loss will be calculated and recorded; intraoperative transfusion requirements will also be noted.
Measured: Intraoperative period (from skin incision to completion of surgery, approximately 30-180 minutes).
Complication Rate
Complications will be identified and classified according to the Clavien-Dindo classification system.
Measured: From intraoperative period through hospital stay and up to 30 days postoperatively.
Residual Stone Rate
Presence of residual stones larger than 4 mm will be recorded; stones ≤4 mm will be considered clinically insignificant.
Measured: At postoperative 1 month, assessed by CT scan.
Length of Hospital Stay
The total number of days of hospitalization will be compared between groups.
Measured: From hospital admission until discharge (typically 2-10 days).
Nephrostomy Tube Duration
The duration (in days) that the nephrostomy tube remains in place will be recorded for each patient.
Measured: From postoperative day 0 (day of surgery) until nephrostomy tube removal, typically within 7-14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Jun 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Nephrolithotomy (PCNL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Arif Burak Keçebaş, Gaziosmanpasa Research and Education Hospital
- Investigators
- Burak Arslan, CLINICAL PROFESSOR OF UROLOGY, Study director, Gaziosmanpaşa Training and Research Hospital, Urology Department, Istanbul, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138872
- Sponsor's protocol ID
- AIBU-SBF-ABK-01
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surgical Position on Hemodynamics in Percutaneous Nephrolithotomy Performed in Prone and Supine Positions
- ClinicalTrials.gov ID
- NCT07138872
- Acronym / sponsor ID
- AIBU-SBF-ABK-01
- Conditions
- Percutaneous Nephrolithotomy (PCNL), Surgical Positioning, Prone Position, Supine Position, Hemodynamic Stability, Nephrolithiasis
- Keywords
- PCNL, Prone Position, Percutaneous Nephrolithotomy, Supine Position, Hemodynamic stability, Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Surgical techniques will be standardized for both positions. Prone PNL will involve initial lithotomy positioning for ureteral catheter placement followed by prone positioning for renal access under fluoroscopic guidance. Supine PNL will be performed in the Galdakao-modified Valdivia position with similar access and fragmentation protocols.
The primary outcome is the difference in intraoperative and postoperative hemodynamic stability between positions. Secondary outcomes include complication rates, residual stone rates, and hospital stay duration.
This study aims to provide high-quality evidence to guide surgeons and anesthesiologists in selecting the optimal patient position for PNL, particularly in individuals with higher hemodynamic risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone Position | Experimental | Procedure: Prone Position Percutaneous NephrolithotomyPatients 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. |
| Supine Position | Experimental | Procedure: Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I-III
- Presence of renal calculi indicated for PNL
Key exclusion criteria (8 listed)
- Pregnancy
- Uncontrolled coagulopathy
- Previous renal surgery
- Severe cardiac, pulmonary, or neurological disease
- Preoperative urinary tract infection (non-sterile urine culture)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone Position Percutaneous NephrolithotomyPatients 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. | Procedure or surgery | Prone Position |
| Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia)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. | Procedure or surgery | Supine Position |
Primary outcome
Change in Hemodynamic Parameters (Intraoperative)
Time frame: 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
Time frame: 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 Diastolic Blood Pressure (Intraoperative)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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-
Time frame: 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 Oxygen Saturation
Time frame: 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 Arterial pCO₂
Time frame: 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.
7 secondary outcomes
Operative Time
Time frame: From initial skin incision until completion of stone removal (approximately 30-180 minutes).
Anesthesia Duration
Time frame: From induction of anesthesia until termination of anesthesia and awakening of the patient (approximately 60-240 minutes).
Intraoperative Blood Loss
Time frame: Intraoperative period (from skin incision to completion of surgery, approximately 30-180 minutes).
Complication Rate
Time frame: From intraoperative period through hospital stay and up to 30 days postoperatively.
Residual Stone Rate
Time frame: At postoperative 1 month, assessed by CT scan.
Length of Hospital Stay
Time frame: From hospital admission until discharge (typically 2-10 days).
Nephrostomy Tube Duration
Time frame: From postoperative day 0 (day of surgery) until nephrostomy tube removal, typically within 7-14 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Burak Arslan, CLINICAL PROFESSOR OF UROLOGY study director
Gaziosmanpaşa Training and Research Hospital, Urology Department, Istanbul, Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Position Percutaneous Nephrolithotomy and Supine Position Percutaneous Nephrolithotomy (Galdakao-modified Valdivia) in people with Percutaneous Nephrolithotomy (PCNL) and Surgical Positioning, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ARİF BURAK KEÇEBAŞ, UROLOGY CLINIC DOCTOR (+90 5412659978, arifkecebas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemodynamic Parameters (Intraoperative) (time frame: From induction of anesthesia to the end of surgery (approximately 60-120 minutes)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.