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Surgical Position and Hemodynamics in PCNL

Completed
Conditions
Percutaneous Nephrolithotomy (PCNL)
Hemodynamic Changes
Surgical Positioning
Registration Number
NCT07109232
Lead Sponsor
Ataturk University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evaluate the effects of supine, lithotomy, and prone position on cardiac cycle efficiency (CCE) during the anesthetic period.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 Outcome Measures
NameTimeMethod
Mean Arterial Pressure assessmentPre-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.

Heart Rate (HR) AssessmentPre-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.

Cardiac Index (CI) AssessmentPre-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.

Stroke Volume Index (SVI) AssessmentPre-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.

dP/dt max AssessmentPre-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.

Arterial Elastance (Ea) AssessmentPre-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.

Cardiac Cycle Efficiency (CCE) AssessmentPre-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.

Cardiac Power Index (CPI) AssessmentPre-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.

Mean Arterial Pressure (MAP) Assessment under General AnesthesiaIntraoperative 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

Heart Rate (HR) Assessment under General AnesthesiaIntraoperative 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.

Cardiac Index (CI) Assessment under General AnesthesiaIntraoperative 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.

Stroke Volume Index (SVI) Assessment under General AnesthesiaIntraoperative 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.

Pulse Pressure Variation (PPV) Assessment under General AnesthesiaIntraoperative 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.

Stroke Volume Variation (SVV) Assessment under General AnesthesiaIntraoperative 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.

dP/dt max Assessment under General AnesthesiaIntraoperative 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.

Arterial Elastance (Ea) Assessment under General AnesthesiaIntraoperative 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.

Cardiac Power Index (CPI) Assessment under General AnesthesiaIntraoperative 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.

Trial Locations

Locations (1)

Atatürk University Faculty of Medicine

🇹🇷

Erzurum, Turkey

Atatürk University Faculty of Medicine
🇹🇷Erzurum, Turkey

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