Surgical Position and Hemodynamics in PCNL

NCT07109232 | Completed

• 1 other identifier: Ataunihemo
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Changes; Surgical Positioning; Percutaneous Nephrolithotomy (PCNL)

Keywords

Nephrolithotomy; Hemodynamics; Surgical position; Monitoring

Outcome Measures

Primary Outcomes (1)

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

  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

  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

Secondary Outcomes (17)

• Mean Arterial Pressure assessment

  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) Assessment

  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) Assessment

  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) Assessment

  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 Assessment

  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)

Study Arms (1)

Hemodynamic Response to Position Changes

Hemodynamic variables-including mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), stroke volume index (SVI), pulse pressure variation (PPV), stroke volume variation (SVV), dP/dtmax, arterial elastance (Ea), cardiac cycle efficiency (CCE), and cardiac power index (CPI)-were continuously monitored. Hemodynamic measurements were obtained at six predefined time points using the Pressure Recording Analytical Method (PRAM). The first three measurements were recorded during the pre-anesthetic period in the supine, lithotomy, and prone positions, respectively, prior to the induction of anesthesia. The latter three measurements were obtained during the anesthetized period: five minutes after induction while the patient was in the baseline supine position, five minutes after transitioning to the lithotomy position (prior to ureteral catheter placement), and five minutes after repositioning to the prone position, before surgical incision.

Other: Position the patient

Interventions

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.

Hemodynamic Response to Position Changes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18-65 years, classified as ASA physical status I-II, with BMI \< 30, undergoing elective percutaneous nephrolithotomy (PCNL) under general anesthesia.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Faculty of Medicine

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (2)

• Lee S, Kim DY, Han J, Kim K, You AH, Kang HY, Park SW, Kim MK, Kim JE, Choi JH. Hemodynamic changes in the prone position according to fluid loading after anaesthesia induction in patients undergoing lumbar spine surgery: a randomized, assessor-blind, prospective study. Ann Med. 2024 Dec;56(1):2356645. doi: 10.1080/07853890.2024.2356645. Epub 2024 May 24.

  PMID: 38794845 BACKGROUND

• Romagnoli S, Franchi F, Ricci Z, Scolletta S, Payen D. The Pressure Recording Analytical Method (PRAM): Technical Concepts and Literature Review. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1460-1470. doi: 10.1053/j.jvca.2016.09.004. Epub 2016 Sep 14. No abstract available.

  PMID: 28012725 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor MD.

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 7, 2025
• Study Start: May 15, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

TU (1)