Hemodynamic Effects of Bone Cement During Hip Arthroplasty Under Neuraxial Anesthesia

NCT07817303 | Completed

• 2 other identifiers: B.30.2.ATA.0.01.00/3332024/05
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hip arthroplasty is a commonly performed surgical procedure in elderly patients, particularly following proximal femoral fractures. During these operations, significant and sudden changes in blood pressure and heart function may occur, especially during bone cement implantation. These hemodynamic alterations may lead to decreased organ perfusion and potential cardiac or renal complications. Traditional non-invasive monitoring methods may not adequately detect rapid perioperative cardiovascular changes. Advanced arterial waveform analysis allows continuous assessment of cardiac output and other hemodynamic parameters in real time. This observational study aims to evaluate perioperative hemodynamic changes in patients undergoing hip arthroplasty under neuraxial anesthesia, comparing cemented and non-cemented procedures. Hemodynamic parameters will be assessed using a pressure recording analytical method through invasive arterial monitoring. In addition, the study investigates the association between intraoperative hemodynamic changes and early postoperative cardiac and renal biomarkers. The findings may contribute to improved perioperative monitoring strategies and safer anesthetic management in high-risk orthopedic surgery patients.

Conditions

Hip Arthroplasty; Bone Cement Implantation Syndrome; Perioperative Hemodynamic Optimization

Keywords

Hemodynamic Monitoring; Pressure Recording Analytical Method; Cardiac Output; Neuraxial Anesthesia Cemented; Hip Arthroplasty; Non-Cemented Hip Arthroplasty; Bone Cement Implantation Syndrome; Arterial Waveform Analysis; Perioperative Anesthesia

Outcome Measures

Primary Outcomes (1)

• Perioperative Change in Cardiac Output Assessed by Arterial Waveform Analysis

  Cardiac output (L/min) is assessed using arterial waveform analysis derived from invasive arterial blood pressure monitoring. Cardiac output values are recorded at predefined perioperative time points: immediately before neuraxial anesthesia (baseline), after neuraxial anesthesia, at surgical incision, immediately before cement or prosthesis implantation, immediately after cement or prosthesis implantation, at the first hypotensive episode if present, and at the end of surgery. The primary outcome is the change in cardiac output across these predefined perioperative time points. Changes over time will be compared between the cemented and non-cemented hip arthroplasty groups.

  From immediately before neuraxial anesthesia through the end of surgery, assessed at predefined perioperative time points, up to 4 hours per participant.

Secondary Outcomes (10)

• Incidence of Intraoperative Hypotension After Cement/Prosthesis Implantation

  From cement/prosthesis implantation until 5 minutes after implantation (intraoperative)

• Perioperative Mean Arterial Pressure Changes

  From baseline measurement to end of surgery (intraoperative)

• Perioperative Stroke Volume Changes

  From baseline measurement to end of surgery (intraoperative)

• Cardiac Power Output Changes During Surgery

  From baseline measurement to end of surgery (intraoperative)

• Cardiac Power Index Changes During Surgery

  From baseline measurement to end of surgery (intraoperative)

Study Arms (2)

Cemented Hip Arthroplasty Group

Patients undergoing hip arthroplasty under neuraxial anesthesia with the use of bone cement. Hemodynamic parameters are recorded perioperatively using arterial waveform analysis as part of routine clinical monitoring.

Other: No intervention (observational study)

Non-Cemented Hip Arthroplasty Group

Patients undergoing hip arthroplasty under neuraxial anesthesia without the use of bone cement. Perioperative hemodynamic parameters are recorded using arterial waveform analysis during routine clinical care.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

This is an observational study. No experimental intervention is assigned. All surgical and anesthetic procedures, including arterial monitoring, are performed as part of standard clinical care.

Cemented Hip Arthroplasty Group; Non-Cemented Hip Arthroplasty Group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 50 to 90 years who are scheduled to undergo hip arthroplasty under neuraxial anesthesia at a tertiary university hospital. Eligible patients have ASA physical status I-III, a body mass index below 30 kg/m², and planned invasive arterial blood pressure monitoring as part of routine perioperative care. Patients are allocated into cemented and non-cemented hip arthroplasty groups according to standard surgical indications. All participants provide written informed consent prior to enrollment.

You may qualify if:

• Age between 50 and 90 years
• Scheduled for hip arthroplasty under neuraxial anesthesia
• ASA physical status I-III
• Body mass index (BMI) \<30 kg/m²
• Planned invasive arterial blood pressure monitoring
• Expected surgical duration \>2 hours
• Ability to provide written informed consent

You may not qualify if:

• Refusal to participate or inability to provide informed consent
• Planned surgery without invasive arterial blood pressure monitoring
• Mean arterial pressure \<65 mmHg at initial monitoring
• Use of vasopressors or inotropes before anesthesia
• Fluid responsiveness detected by Trendelenburg maneuver
• Intraoperative blood loss exceeding tolerable limits
• Additional epidural drug administration during cement implantation
• Estimated glomerular filtration rate \<30 mL/min/1.73 m²
• Ongoing renal replacement therapy
• Preoperative intensive care unit requirement
• NYHA class III-IV heart failure or left ventricular ejection fraction \<40%
• Severe valvular heart disease
• Persistent cardiac arrhythmia
• Coagulation disorders
• Sensory block level below T8 after initial neuraxial anesthesia

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (3)

• 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

• Hines CB. Understanding Bone Cement Implantation Syndrome. AANA J. 2018 Dec;86(6):433-441.

  PMID: 31584416 BACKGROUND

• Donaldson AJ, Thomson HE, Harper NJ, Kenny NW. Bone cement implantation syndrome. Br J Anaesth. 2009 Jan;102(1):12-22. doi: 10.1093/bja/aen328.

  PMID: 19059919 BACKGROUND

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Muhammed Enes Aydın, Principal Investigator

  Ataturk University Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 14, 2026
• Study Start: March 1, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 15, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)