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Completed

NCT Number: NCT07109232

Surgical Position and Hemodynamics in PCNL

This prospective study aims to evaluate the hemodynamic effects of different surgical positions-supine, lithotomy, and prone-in patients undergoing percutaneous nephrolithotomy (PCNL). Hemodynamic parameters are assessed using the Pressure Recording Analytical Method (PRAM) both while patients are awake and under general anesthesia. The study investigates how positioning-independently and in combination with anesthesia-influences cardiovascular function, including mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), stroke volume index (SVI), pulse pressure variation (PPV), stroke volume variation (SVV), cardiac contractility parameters (dP/dtmax), arterial elastance (Ea), cardiac power index (CPI), and cardiac cycle efficiency (CCE). The findings are expected to contribute to optimizing perioperative management and enhancing patient safety during PCNL procedures.

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Key information

Conditions

Hemodynamic Changes Percutaneous Nephrolithotomy (PCNL) Surgical Positioning

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Atatürk University Faculty of Medicine

Erzurum, 25100, Turkey (Türkiye)

About this study

This prospective clinical trial investigates the hemodynamic effects of different surgical positions-supine, lithotomy, and prone-in patients undergoing percutaneous nephrolithotomy (PCNL). The study evaluates hemodynamic variables both in the awake state and under general anesthesia to distinguish the individual and combined impacts of anesthesia and patient positioning on cardiovascular function.

Hemodynamic measurements are performed using the Pressure Recording Analytical Method (PRAM), a minimally invasive technique that allows continuous assessment of parameters such as mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), pulse pressure variation (PPV), stroke volume variation (SVV), stroke volume index (SVI), cardiac contractility parameters (dP/dtmax), arterial elastance (Ea), cardiac power index (CPI), and cardiac cycle efficiency (CCE). Each patient is sequentially positioned in the three surgical positions while awake, and the same measurements are repeated after the induction of general anesthesia in the corresponding positions.

The primary aim is to determine how surgical positioning under general anesthesia alters key cardiovascular parameters. Secondary objectives include comparing hemodynamic changes across positions in both conscious and anesthetized states, identifying potential risks associated with specific positions, and guiding intraoperative patient management to improve safety and outcomes in PCNL procedures.

The study is conducted at a single center and includes adult patients with ASA physical status I-II scheduled for elective PCNL surgery. The findings are expected to provide valuable data for anesthesiologists and surgeons to optimize perioperative cardiovascular stability, particularly during position changes in urological surgeries.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must be between 18 and 65 years of age. Participants must have a body mass index (BMI) of less than 30 kg/m². Participants must be classified as American Society of Anesthesiologists (ASA) physical status I or II.

Participants must be scheduled to undergo elective percutaneous nephrolithotomy (PCNL) surgery.

Exclusion criteria

Participants with a known history of cardiac disease, including arrhythmia, valvular heart disease, prior cardiac surgery, presence of a pacemaker, or an implanted cardiac defibrillator, will be excluded.

Participants with renal failure will be excluded. Participants who received colloid fluid administration prior to surgery will be excluded.

Participants using vasoactive or inotropic drugs will be excluded.

Treatment and study plan

Position the patient

Other

In addition, prior to the operation and throughout the PCNL procedure, hemodynamic measurements were obtained while patients were positioned in the supine, lithotomy, and prone positions, as necessitated by the surgical protocol.

Primary outcomes

  1. Evaluate the effects of supine, lithotomy, and prone position on cardiac cycle efficiency (CCE) during the anesthetic period.

    Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position

    The primary objective was to evaluate the effects of different surgical positions on cardiac cycle efficiency (CCE), a parameter derived from pulse contour analysis during the anesthetic period. First measurement was recorded five minutes after anesthesia induction, while the patient was in the baseline supine position. Second measurement was recorded five minutes after transitioning to the lithotomy position, prior to ureteral catheter insertion. The third measurement was recorded five minutes after repositioning to the prone position

Secondary outcomes

  1. Mean Arterial Pressure assessment

    Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)

    Mean Arterial Pressure (MAP), derived via the PRAM method, was assessed in awake patients at three predefined surgical positions.

  2. Heart Rate (HR) Assessment

    Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)

    Heart Rate (HR) was recorded using the PRAM method in awake patients at three predefined surgical positions.

  3. Cardiac Index (CI) Assessment

    Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)

    Cardiac Index (CI) was measured using the PRAM method in awake patients at three predefined surgical positions.

  4. Stroke Volume Index (SVI) Assessment

    Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)

    Stroke Volume Index (SVI) was assessed via the PRAM method in awake patients at three predefined surgical positions.

  5. dP/dt max Assessment

    Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)

    dP/dt max, an index of cardiac contractility, was assessed using the PRAM method in awake patients at three predefined surgical positions.

  6. Arterial Elastance (Ea) Assessment

    Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)

    Arterial Elastance (Ea) was measured using the PRAM method in awake patients at three predefined surgical positions.

  7. Cardiac Cycle Efficiency (CCE) Assessment

    Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)

    Cardiac Cycle Efficiency (CCE) was derived using the PRAM method in awake patients at three predefined surgical positions.

  8. Cardiac Power Index (CPI) Assessment

    Time frame: Pre-anesthetic period at three predefined time points: 1) before anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)

    Cardiac Power Index (CPI) was assessed using the PRAM method in awake patients at three predefined surgical positions.

  9. Mean Arterial Pressure (MAP) Assessment under General Anesthesia

    Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position

    Mean Arterial Pressure (MAP) was measured using the PRAM method in patients under general anesthesia at three surgical positions in the operating room

  10. Heart Rate (HR) Assessment under General Anesthesia

    Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position

    Heart Rate (HR) was recorded using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.

  11. Cardiac Index (CI) Assessment under General Anesthesia

    Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position

    Cardiac Index (CI) was assessed using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.

  12. Stroke Volume Index (SVI) Assessment under General Anesthesia

    Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position

    Stroke Volume Index (SVI) was measured using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.

  13. Pulse Pressure Variation (PPV) Assessment under General Anesthesia

    Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position

    Pulse Pressure Variation (PPV) was measured using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.

  14. Stroke Volume Variation (SVV) Assessment under General Anesthesia

    Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position

    Stroke Volume Variation (SVV) was assessed using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.

  15. dP/dt max Assessment under General Anesthesia

    Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position

    dP/dt max, an index of cardiac contractility, was assessed using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.

  16. Arterial Elastance (Ea) Assessment under General Anesthesia

    Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position

    Arterial Elastance (Ea) was measured using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.

  17. Cardiac Power Index (CPI) Assessment under General Anesthesia

    Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position

    Cardiac Power Index (CPI) was assessed using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Hemodynamic Effects of Surgical Positioning in Patients Undergoing Percutaneous Nephrolithotomy: A Prospective Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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