Hip ArthroplastyHIP-PRAMNCT07817303
Hemodynamic Effects of Bone Cement During Hip Arthroplasty Under Neuraxial Anesthesia
An observational study of Hip Arthroplasty and Bone Cement Implantation Syndrome, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Hip Arthroplasty, Bone Cement Implantation Syndrome, Perioperative Hemodynamic Optimization
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 15 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Perioperative Hemodynamic Changes and Bone Cement Implantation Syndrome Using Pressure Recording Analytical Method in Patients Undergoing Hip Arthroplasty Under Neuraxial Anesthesia
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.
Read more
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.
Read the detailed description
Perioperative hemodynamic monitoring is a cornerstone of anesthetic management, enabling the assessment of cardiovascular function and optimization of organ perfusion. Hip arthroplasty is frequently performed in elderly patients and is associated with a risk of significant hemodynamic instability, particularly during bone cement implantation. Bone Cement Implantation Syndrome is characterized by hypotension, hypoxia, and cardiovascular collapse, which may result in postoperative organ dysfunction.
In this prospective observational study, patients undergoing hip arthroplasty under neuraxial anesthesia are evaluated to characterize perioperative hemodynamic changes using continuous arterial waveform analysis. A pressure recording analytical method is used to measure cardiac output and related hemodynamic parameters through invasive arterial blood pressure monitoring.
Patients aged 50 to 90 years with ASA physical status I-III scheduled for elective or fracture-related hip arthroplasty are included. Eligible patients are divided into two groups according to surgical technique: cemented and non-cemented hip arthroplasty. No intervention or randomization is performed; surgical and anesthetic management follow routine clinical practice.
Hemodynamic parameters are recorded at predefined time points, including baseline measurements, after neuraxial anesthesia, at surgical incision, before and after cement or prosthesis implantation, during the first hypotensive episode if present, and at the end of surgery. Fluid responsiveness is assessed using Trendelenburg maneuver-induced changes in cardiac output and stroke volume.
Arterial blood gas analysis is performed intraoperatively as clinically indicated and routinely at the end of surgery. Postoperative laboratory assessments include serum creatinine, NT-proBNP, and troponin I measured on postoperative day 0, followed by daily measurements on postoperative days 1, 2, and 3. Urine output is monitored during the postoperative period.
The primary objective of the study is to evaluate perioperative hemodynamic changes associated with bone cement implantation. Secondary objectives include assessing the relationship between intraoperative hemodynamic alterations and early postoperative cardiac and renal biomarkers. All collected data are analyzed statistically to determine differences between cemented and non-cemented procedures and to explore potential predictors of organ dysfunction.
- Conditions
- Hip Arthroplasty, Bone Cement Implantation Syndrome, Perioperative Hemodynamic Optimization
- Being tested
- No intervention (observational study)
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Incidence of hypotension defined as MAP <65 mmHg occurring after cement or prosthesis implantation. The first hypotensive episode is recorded; if hypotension does not occur, hemodynamic values at 5 minutes after implantation are used for comparison between groups.
Measured: From cement/prosthesis implantation until 5 minutes after implantation (intraoperative)
Perioperative Mean Arterial Pressure Changes
MAP values recorded at predefined intraoperative time points (baseline, after neuraxial anesthesia, incision, pre-implantation, post-implantation/first hypotension or 5th minute, end of surgery) and compared between cemented and non-cemented groups.
Measured: From baseline measurement to end of surgery (intraoperative)
Perioperative Stroke Volume Changes
Stroke volume values measured by arterial waveform analysis and recorded at predefined intraoperative time points (baseline, after neuraxial anesthesia, incision, pre-implantation, post-implantation/first hypotension or 5th minute, end of surgery). Group comparisons are performed.
Measured: From baseline measurement to end of surgery (intraoperative)
Cardiac Power Output Changes During Surgery
Cardiac power output values derived from arterial waveform analysis are recorded at predefined intraoperative time points and compared between cemented and non-cemented hip arthroplasty groups.
Measured: From baseline measurement to end of surgery (intraoperative)
Cardiac Power Index Changes During Surgery
Cardiac power index values derived from arterial waveform analysis are recorded at predefined intraoperative time points and compared between cemented and non-cemented hip arthroplasty groups.
Measured: From baseline measurement to end of surgery (intraoperative)
Fluid Responsiveness Assessed by Trendelenburg Maneuver
Changes in cardiac output and stroke volume in response to Trendelenburg maneuver are recorded to assess fluid responsiveness prior to neuraxial anesthesia, using arterial waveform analysis.
Measured: Pre-anesthesia period (after arterial line placement, before neuraxial anesthesia)
Postoperative Troponin I Levels
Troponin I levels measured from arterial blood samples postoperatively on day 0 and daily on postoperative days 1, 2, and 3. Values are compared between groups and evaluated in relation to intraoperative hemodynamic changes.
Measured: Postoperative day 0 to postoperative day 3
Postoperative NT-proBNP Levels
NT-proBNP levels measured from arterial blood samples postoperatively on day 0 and daily on postoperative days 1, 2, and 3. Values are compared between groups and evaluated in relation to intraoperative hemodynamic changes.
Measured: Postoperative day 0 to postoperative day 3
Postoperative Serum Creatinine Levels
Serum creatinine measured postoperatively on day 0 and daily on postoperative days 1, 2, and 3. Group comparisons are performed and associations with intraoperative hemodynamic changes are explored.
Measured: Postoperative day 0 to postoperative day 3
Postoperative Urine Output
Urine output recorded on postoperative days 1, 2, and 3 as an indicator of renal function, compared between cemented and non-cemented groups and evaluated in relation to intraoperative hemodynamic changes.
Measured: Postoperative day 1 to postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Mar 2026
- Primary completion1 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed E Aydin, Ataturk University
- Investigators
- Muhammed Enes Aydın, Principal Investigator, Principal investigator, Ataturk University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817303
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/333
- Other IDs
- 2024/05
- Acronym
- HIP-PRAM
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional and ethical restrictions. The study is a single-center observational study with a limited sample size, and informed consent did not include provisions for data sharing. All data are analyzed and reported in aggregate form to ensure participant confidentiality.
Publications
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.
PubMed 28012725Hines CB. Understanding Bone Cement Implantation Syndrome. AANA J. 2018 Dec;86(6):433-441.
PubMed 31584416Donaldson 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.
PubMed 19059919
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Hemodynamic Changes and Bone Cement Implantation Syndrome Using Pressure Recording Analytical Method in Patients Undergoing Hip Arthroplasty Under Neuraxial Anesthesia
- ClinicalTrials.gov ID
- NCT07817303
- Acronym / sponsor ID
- HIP-PRAM / B.30.2.ATA.0.01.00/333
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 14 Sep 2026 (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.
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.
Detailed description
Perioperative hemodynamic monitoring is a cornerstone of anesthetic management, enabling the assessment of cardiovascular function and optimization of organ perfusion. Hip arthroplasty is frequently performed in elderly patients and is associated with a risk of significant hemodynamic instability, particularly during bone cement implantation. Bone Cement Implantation Syndrome is characterized by hypotension, hypoxia, and cardiovascular collapse, which may result in postoperative organ dysfunction.
In this prospective observational study, patients undergoing hip arthroplasty under neuraxial anesthesia are evaluated to characterize perioperative hemodynamic changes using continuous arterial waveform analysis. A pressure recording analytical method is used to measure cardiac output and related hemodynamic parameters through invasive arterial blood pressure monitoring.
Patients aged 50 to 90 years with ASA physical status I-III scheduled for elective or fracture-related hip arthroplasty are included. Eligible patients are divided into two groups according to surgical technique: cemented and non-cemented hip arthroplasty. No intervention or randomization is performed; surgical and anesthetic management follow routine clinical practice.
Hemodynamic parameters are recorded at predefined time points, including baseline measurements, after neuraxial anesthesia, at surgical incision, before and after cement or prosthesis implantation, during the first hypotensive episode if present, and at the end of surgery. Fluid responsiveness is assessed using Trendelenburg maneuver-induced changes in cardiac output and stroke volume.
Arterial blood gas analysis is performed intraoperatively as clinically indicated and routinely at the end of surgery. Postoperative laboratory assessments include serum creatinine, NT-proBNP, and troponin I measured on postoperative day 0, followed by daily measurements on postoperative days 1, 2, and 3. Urine output is monitored during the postoperative period.
The primary objective of the study is to evaluate perioperative hemodynamic changes associated with bone cement implantation. Secondary objectives include assessing the relationship between intraoperative hemodynamic alterations and early postoperative cardiac and renal biomarkers. All collected data are analyzed statistically to determine differences between cemented and non-cemented procedures and to explore potential predictors of organ dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented Hip Arthroplasty Group | – | Other: No intervention (observational study)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. |
| Non-Cemented Hip Arthroplasty Group | – | Other: No intervention (observational study)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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| No intervention (observational study)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. | Other | Cemented Hip Arthroplasty Group, Non-Cemented Hip Arthroplasty Group |
Primary outcome
Perioperative Change in Cardiac Output Assessed by Arterial Waveform Analysis
Time frame: From immediately before neuraxial anesthesia through the end of surgery, assessed at predefined perioperative time points, up to 4 hours per participant.
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.
10 secondary outcomes
Incidence of Intraoperative Hypotension After Cement/Prosthesis Implantation
Time frame: From cement/prosthesis implantation until 5 minutes after implantation (intraoperative)
Perioperative Mean Arterial Pressure Changes
Time frame: From baseline measurement to end of surgery (intraoperative)
Perioperative Stroke Volume Changes
Time frame: From baseline measurement to end of surgery (intraoperative)
Cardiac Power Output Changes During Surgery
Time frame: From baseline measurement to end of surgery (intraoperative)
Cardiac Power Index Changes During Surgery
Time frame: From baseline measurement to end of surgery (intraoperative)
Fluid Responsiveness Assessed by Trendelenburg Maneuver
Time frame: Pre-anesthesia period (after arterial line placement, before neuraxial anesthesia)
Postoperative Troponin I Levels
Time frame: Postoperative day 0 to postoperative day 3
Postoperative NT-proBNP Levels
Time frame: Postoperative day 0 to postoperative day 3
Postoperative Serum Creatinine Levels
Time frame: Postoperative day 0 to postoperative day 3
Postoperative Urine Output
Time frame: Postoperative day 1 to postoperative day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 28012725Romagnoli 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.
- Background: PubMed 31584416Hines CB. Understanding Bone Cement Implantation Syndrome. AANA J. 2018 Dec;86(6):433-441.
- Background: PubMed 19059919Donaldson 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional and ethical restrictions. The study is a single-center observational study with a limited sample size, and informed consent did not include provisions for data sharing. All data are analyzed and reported in aggregate form to ensure participant confidentiality.
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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. This study is not recruiting at the moment.
Muhammed Enes Aydın, Principal Investigator principal investigator
Ataturk University Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthroplasty and Bone Cement Implantation Syndrome, run by Ataturk University 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 14 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Change in Cardiac Output Assessed by Arterial Waveform Analysis (time frame: From immediately before neuraxial anesthesia through the end of surgery, assessed at predefined perioperative time points, up to 4 hours per participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07817303, which also lists 3 linked publications.
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 14 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.