Cardiac AnaesthesiaAPECxNCT07255924
Anesthesia, Perfusion, and Surgical practicEs in Cardiac Surgery
An observational study of Cardiac Anaesthesia and Cardiac Surgery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Perioperative management in cardiac surgery, particularly the use of anesthesia, cardiopulmonary bypass (CPB), and surgical techniques, remains highly variable across institutions. Current international guidelines lack clear recommendations due to insufficient high-quality comparative data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Anaesthesia, Cardiac Surgery, Perfusion
- How many people
- 15,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2026to Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing cardiac surgery at one of the participating centers.
Who may be able to join
- 18 years or older
- Undergoing cardiac surgery at a participating center
Who cannot join
- Transcatheter cardiac interventions or endovascular procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne M Beukers, MD, PhD contact
Netherlands1 site
Amsterdam UMC, Location AMC
Amsterdam, North Holland, 1105AZ
Jord C Seegers, MD, +3120 566 9111, j.c.seegers@amsterdamumc.nl
About this study
Official title: Anesthesia, Perfusion, and Surgical practicEs in Cardiac Surgery: an Adaptive, Prospective, International, Multicenter, Observational Study.
Perioperative management in cardiac surgery, particularly the use of anesthesia, cardiopulmonary bypass (CPB), and surgical techniques, remains highly variable across institutions. Current international guidelines lack clear recommendations due to insufficient high-quality comparative data. APECx is an adaptive, international, multicenter, prospective, observational study designed to address multiple of these evidence gaps. The adaptive design allows the study to proceed through subsequent phases. Each phase will collect comprehensive global data on specific peri-operative practices and their associated patient outcomes, all within a single, continuously evolving study.
Read the detailed description
The perioperative management, particularly the use of anesthesia, cardiopulmonary bypass (CPB) and surgical techniques in cardiac surgery, remains highly variable across institutions and regions. Current international guidelines lack clear recommendations due to the insufficiency of high-quality comparative data. Furthermore, over two thirds of the recommendations continue to rely on expert opinion, with little change over time. Given the complexity and physiological burden of cardiac surgery, understanding global variation in anesthetic, perfusion and surgical strategies is critical.
The APECx initiative is an adaptive, international, multicenter, prospective cohort study designed to address multiple of these knowledge gaps. The study aims to promote consistent, evidence-based care by describing global practice variationsand identifying potential modifiable factors that are associated with clinical outcomes.
The core feature of the APECx study is its adaptive design that allows the research focus to evolve over time. The study will proceed through distinct phases, beginning in 2026. Each phase will span approximately one year, concluding once the phase-specific, predefined sample size is reached, at which point the study will transition to the next phase. This framework enables the collection of comprehensive data on specific practices and outcomes within a single, continuously evolving study. To ensure transparency and reproducibility, a detailed protocol for each study phase will be registered on ClinicalTrials.gov prior to phase start.
All data will be prospectively collected by local investigators and entered into a web-based electronic Case Report Form (eCRF) using Castor (Castor Electronic Data Capture, Amsterdam, the Netherlands). Data collection will occur biannually, with participating centers collecting data for a period of two consecutive weeks within a designated three-month window. Follow-up will continue for 30 days post-surgery or until hospital discharge, whichever comes first.
This study will be conducted at cardiac surgery centers worldwide. An inclusive enrollment strategy aims to recruit a broad spectrum of centers, varying in research involvement, surgical complexity, annual caseload, and geographic location, to ensure a globally representative dataset. Centers will have the flexibility to join or leave the study at the beginning of each new phase, a design feature intended to lower the threshold for participation.
- Conditions
- Cardiac Anaesthesia, Cardiac Surgery, Perfusion, Anesthesia
- Keywords
- Cardiac Surgery, Cardiac Anaesthesia, Anesthesia, Perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | The Phase 1 cohort comprises all participants enrolled during the first phase of the APECx study. The primary focus for this phase/group is to identify global mechanical ventilation strategies and their associations with key clinical outcomes, including the incidence of post-operative pulmonary complications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Hospital length of stay (LOS) refers to the total duration (in days) of a patient's admission in the hospital.
Measured: From date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.
Intensive Care Unit (ICU) length of stay
Intensive Care Unit (ICU) length of stay (LOS) is the duration (in days) a participant spends postoperatively in the ICU.
Measured: From the time of ICU admission immediately after cardiac surgery until transfer out of the ICU, assessed up to 30 days postoperatively.
All-cause in-hospital 30-day mortality
All-cause in-hospital 30-day mortality refers to death from any cause during the hospital stay within 30 days after cardiac surgery.
Measured: From the date of surgery until death, assessed up to 30 days postoperatively.
Postoperative pulmonary complications
Postoperative pulmonary complications (PPCs) are a composite of pulmonary events occurring within the first 5 postoperative days, including: - Mild respiratory failure: SpO₂ <90% or PaO₂ <7.9 kPa on room air, increased oxygen need, or oxygen use >2 days; - Severe respiratory failure: ventilatory support or hypoxemia despite oxygen; - Bronchospasm: new wheeze treated with bronchodilator; - Suspected infection: antibiotics plus new sputum, opacities, fever >38.3°C, or WBC >12,000/μL; - Pulmonary infiltrate: any unilateral or bilateral infiltrates on chest X-ray; - Aspiration pneumonitis: respiratory failure following inhalation of gastric contents; - Atelectasis: opacification with mediastinal shift and compensatory overinflation; - ARDS: as per global 2023 definition; - Pleural effusion: blunted costophrenic angle or hazy opacity; - Cardiopulmonary edema: congestion signs and interstitial infiltrates; and - Pneumothorax: air in pleural space with absent vascular markings.
Measured: Directly after cardiac surgery until the fifth postoperative day.
Duration of mechanical ventilation
Total duration (in hours) a patient peri-operatively receives support form a mechanical ventilator. Defined as the time (in hours) from intubation to the first extubation.
Measured: From the initiation of mechanical ventilation until the first discontinuation of mechanical ventilation, assessed up to 30 days postoperatively.
Secondary outcomes (7)
Acute Kidney Injury (AKI)
Incidence of Acute Kidney Injury as defined by the KDIGO 2012 criteria.
Measured: Directly after cardiac surgery up to 30 days postoperatively.
Postoperative stroke
Post-operative stroke is defined as a cerebrovascular event (either ischemic or hemorrhagic) occurring within 30 days following cardiac surgery. The diagnosis is based on the onset of neurological deficits that may be temporary or persist long term, with confirmation via neuroimaging (CT or MRI) when possible.
Measured: Directly after cardiac surgery up to 30 days postoperatively.
Need for cardiac mechanical circulatory and/or cardiac, respiratory or cardiorespiratory extracorporeal life support modalities
The incidence of postoperative use of cardiac mechanical circulatory (e.g. intra-aortic balloon pump, Impella) and/or cardiac, respiratory or cardiorespiratory extracorporeal life support (ECLS) modalities.
Measured: Directly after cardiac surgery up to 30 days postoperatively.
Postoperative Myocardial Infarction
Postoperative myocardial infarction is a heart attack that occurs within the 30 days following cardiac surgery. The diagnosis requires evidence of new myocardial injury, primarily detected by an elevation in cardiac troponin or Creatine Kinase MB (CK-MB) levels, along with other clinical signs of ischemia like specific ECG changes or new wall motion abnormalities on imaging.
Measured: Directly after cardiac surgery up to 30 days postoperatively.
New-onset postoperative atrial fibrilliation
New-onset postoperative atrial fibrillation is the development of atrial fibrillation within the first 30 days following cardiac surgery in participants who were not previously diagnosed with atrial fibrillation
Measured: Directly after cardiac surgery up to 30 days postoperatively.
Postoperative chest tube bloodloss
Postoperative chest tube blood loss is the measured volume of blood drained from the chest cavity through surgically placed tubes following cardiac surgery.
Measured: Measured in the first 12 hours after cardiac surgery
Postoperative transfustion rates
Defined as the number of units of erythrocytes (red blood cells), thrombocytes (platelets), and fresh frozen plasma (FFP) postoperatively transfused to each participant.
Measured: Directly after cardiac surgery up to 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Apr 2026 (estimated)
- Primary completionJan 2036 (estimated)
- Study completionJan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- 15,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location AMC, VU University of Amsterdam
- Responsible party
- Principal investigator, Nimrat Grewal, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Anne M Beukers, MD, PhD, Study chair, Amsterdam UMCDavid MP van Meenen, MD, PhD, Study chair, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255924
- Sponsor's protocol ID
- 2025.0597
- Acronym
- APECx
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Belway D, Tee R, Nathan HJ, Rubens FD, Boodhwani M. Temperature management and monitoring practices during adult cardiac surgery under cardiopulmonary bypass: results of a Canadian national survey. Perfusion. 2011 Sep;26(5):395-400. doi: 10.1177/0267659111409095. Epub 2011 May 18.
PubMed 21593083Klein A, Agarwal S, Cholley B, Fassl J, Griffin M, Kaakinen T, Mzallassi Z, Paulus P, Rex S, Siegemund M, van Saet A. A survey of patient blood management for patients undergoing cardiac surgery in nine European countries. J Clin Anesth. 2021 Sep;72:110311. doi: 10.1016/j.jclinane.2021.110311. Epub 2021 Apr 24.
PubMed 33905900Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.
PubMed 29661384Authors/Task Force Members:; Jeppsson A; (Co-Chairperson) (Sweden); Rocca B; (Co-Chairperson) (Italy); Hansson EC; (Sweden); Gudbjartsson T; (Iceland); James S; (Sweden); Kaski JC; (United Kingdom); Landmesser U; (Germany); Landoni G; (Italy); Magro P; (Portugal); Pan E; (Finland); Ravn HB; (Denmark); Sandner S; (Austria); Sandoval E; (Spain); Uva MS; (Portugal); Milojevic M; (Serbia); EACTS Scientific Document Group. 2024 EACTS Guidelines on perioperative medication in adult cardiac surgery. Eur J Cardiothorac Surg. 2024 Dec 26;67(1):ezae355. doi: 10.1093/ejcts/ezae355. No abstract available.
PubMed 39385505Authors/Task Force Members; Kunst G, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Puis L, Wahba A; EACTS/EACTA/EBCP Committee Reviewers; Alston P, Fitzgerald D, Nikolic A, Onorati F, Rasmussen BS, Svenmarker S. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Br J Anaesth. 2019 Dec;123(6):713-757. doi: 10.1016/j.bja.2019.09.012. Epub 2019 Oct 2. No abstract available.
PubMed 31585674
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia, Perfusion, and Surgical practicEs in Cardiac Surgery: an Adaptive, Prospective, International, Multicenter, Observational Study.
- ClinicalTrials.gov ID
- NCT07255924
- Acronym / sponsor ID
- APECx / 2025.0597
- Conditions
- Cardiac Anaesthesia, Cardiac Surgery, Perfusion, Anesthesia
- Keywords
- Cardiac Surgery, Cardiac Anaesthesia, Anesthesia, Perfusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Amsterdam UMC, location AMC, VU University of Amsterdam
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Jan 2036 (estimated)
- Study completion
- Jan 2036 (estimated)
- First posted
- 1 Dec 2025 (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.
Perioperative management in cardiac surgery, particularly the use of anesthesia, cardiopulmonary bypass (CPB), and surgical techniques, remains highly variable across institutions. Current international guidelines lack clear recommendations due to insufficient high-quality comparative data. APECx is an adaptive, international, multicenter, prospective, observational study designed to address multiple of these evidence gaps. The adaptive design allows the study to proceed through subsequent phases. Each phase will collect comprehensive global data on specific peri-operative practices and their associated patient outcomes, all within a single, continuously evolving study.
Detailed description
The perioperative management, particularly the use of anesthesia, cardiopulmonary bypass (CPB) and surgical techniques in cardiac surgery, remains highly variable across institutions and regions. Current international guidelines lack clear recommendations due to the insufficiency of high-quality comparative data. Furthermore, over two thirds of the recommendations continue to rely on expert opinion, with little change over time. Given the complexity and physiological burden of cardiac surgery, understanding global variation in anesthetic, perfusion and surgical strategies is critical.
The APECx initiative is an adaptive, international, multicenter, prospective cohort study designed to address multiple of these knowledge gaps. The study aims to promote consistent, evidence-based care by describing global practice variationsand identifying potential modifiable factors that are associated with clinical outcomes.
The core feature of the APECx study is its adaptive design that allows the research focus to evolve over time. The study will proceed through distinct phases, beginning in 2026. Each phase will span approximately one year, concluding once the phase-specific, predefined sample size is reached, at which point the study will transition to the next phase. This framework enables the collection of comprehensive data on specific practices and outcomes within a single, continuously evolving study. To ensure transparency and reproducibility, a detailed protocol for each study phase will be registered on ClinicalTrials.gov prior to phase start.
All data will be prospectively collected by local investigators and entered into a web-based electronic Case Report Form (eCRF) using Castor (Castor Electronic Data Capture, Amsterdam, the Netherlands). Data collection will occur biannually, with participating centers collecting data for a period of two consecutive weeks within a designated three-month window. Follow-up will continue for 30 days post-surgery or until hospital discharge, whichever comes first.
This study will be conducted at cardiac surgery centers worldwide. An inclusive enrollment strategy aims to recruit a broad spectrum of centers, varying in research involvement, surgical complexity, annual caseload, and geographic location, to ensure a globally representative dataset. Centers will have the flexibility to join or leave the study at the beginning of each new phase, a design feature intended to lower the threshold for participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | –The Phase 1 cohort comprises all participants enrolled during the first phase of the APECx study. The primary focus for this phase/group is to identify global mechanical ventilation strategies and their associations with key clinical outcomes, including the incidence of post-operative pulmonary complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing cardiac surgery at one of the participating centers.
Key inclusion criteria (2 listed)
- 18 years or older
- Undergoing cardiac surgery at a participating center
Key exclusion criteria (1 listed)
- Transcatheter cardiac interventions or endovascular procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital length of stay
Time frame: From date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.
Hospital length of stay (LOS) refers to the total duration (in days) of a patient's admission in the hospital.
Intensive Care Unit (ICU) length of stay
Time frame: From the time of ICU admission immediately after cardiac surgery until transfer out of the ICU, assessed up to 30 days postoperatively.
Intensive Care Unit (ICU) length of stay (LOS) is the duration (in days) a participant spends postoperatively in the ICU.
All-cause in-hospital 30-day mortality
Time frame: From the date of surgery until death, assessed up to 30 days postoperatively.
All-cause in-hospital 30-day mortality refers to death from any cause during the hospital stay within 30 days after cardiac surgery.
Postoperative pulmonary complications
Time frame: Directly after cardiac surgery until the fifth postoperative day.
Postoperative pulmonary complications (PPCs) are a composite of pulmonary events occurring within the first 5 postoperative days, including: - Mild respiratory failure: SpO₂ <90% or PaO₂ <7.9 kPa on room air, increased oxygen need, or oxygen use >2 days; - Severe respiratory failure: ventilatory support or hypoxemia despite oxygen; - Bronchospasm: new wheeze treated with bronchodilator; - Suspected infection: antibiotics plus new sputum, opacities, fever >38.3°C, or WBC >12,000/μL; - Pulmonary infiltrate: any unilateral or bilateral infiltrates on chest X-ray; - Aspiration pneumonitis: respiratory failure following inhalation of gastric contents; - Atelectasis: opacification with mediastinal shift and compensatory overinflation; - ARDS: as per global 2023 definition; - Pleural effusion: blunted costophrenic angle or hazy opacity; - Cardiopulmonary edema: congestion signs and interstitial infiltrates; and - Pneumothorax: air in pleural space with absent vascular markings.
Duration of mechanical ventilation
Time frame: From the initiation of mechanical ventilation until the first discontinuation of mechanical ventilation, assessed up to 30 days postoperatively.
Total duration (in hours) a patient peri-operatively receives support form a mechanical ventilator. Defined as the time (in hours) from intubation to the first extubation.
7 secondary outcomes
Acute Kidney Injury (AKI)
Time frame: Directly after cardiac surgery up to 30 days postoperatively.
Postoperative stroke
Time frame: Directly after cardiac surgery up to 30 days postoperatively.
Need for cardiac mechanical circulatory and/or cardiac, respiratory or cardiorespiratory extracorporeal life support modalities
Time frame: Directly after cardiac surgery up to 30 days postoperatively.
Postoperative Myocardial Infarction
Time frame: Directly after cardiac surgery up to 30 days postoperatively.
New-onset postoperative atrial fibrilliation
Time frame: Directly after cardiac surgery up to 30 days postoperatively.
Postoperative chest tube bloodloss
Time frame: Measured in the first 12 hours after cardiac surgery
Postoperative transfustion rates
Time frame: Directly after cardiac surgery up to 30 days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Background: PubMed 21593083Belway D, Tee R, Nathan HJ, Rubens FD, Boodhwani M. Temperature management and monitoring practices during adult cardiac surgery under cardiopulmonary bypass: results of a Canadian national survey. Perfusion. 2011 Sep;26(5):395-400. doi: 10.1177/0267659111409095. Epub 2011 May 18.
- Background: PubMed 33905900Klein A, Agarwal S, Cholley B, Fassl J, Griffin M, Kaakinen T, Mzallassi Z, Paulus P, Rex S, Siegemund M, van Saet A. A survey of patient blood management for patients undergoing cardiac surgery in nine European countries. J Clin Anesth. 2021 Sep;72:110311. doi: 10.1016/j.jclinane.2021.110311. Epub 2021 Apr 24.
- Background: PubMed 29661384Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.
- Background: PubMed 39385505Authors/Task Force Members:; Jeppsson A; (Co-Chairperson) (Sweden); Rocca B; (Co-Chairperson) (Italy); Hansson EC; (Sweden); Gudbjartsson T; (Iceland); James S; (Sweden); Kaski JC; (United Kingdom); Landmesser U; (Germany); Landoni G; (Italy); Magro P; (Portugal); Pan E; (Finland); Ravn HB; (Denmark); Sandner S; (Austria); Sandoval E; (Spain); Uva MS; (Portugal); Milojevic M; (Serbia); EACTS Scientific Document Group. 2024 EACTS Guidelines on perioperative medication in adult cardiac surgery. Eur J Cardiothorac Surg. 2024 Dec 26;67(1):ezae355. doi: 10.1093/ejcts/ezae355. No abstract available.
- Background: PubMed 31585674Authors/Task Force Members; Kunst G, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Puis L, Wahba A; EACTS/EACTA/EBCP Committee Reviewers; Alston P, Fitzgerald D, Nikolic A, Onorati F, Rasmussen BS, Svenmarker S. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Br J Anaesth. 2019 Dec;123(6):713-757. doi: 10.1016/j.bja.2019.09.012. Epub 2019 Oct 2. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Anaesthesia
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Not yet recruitingObservational study
Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
Frailty, Suboptimal Mask Ventilation
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
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.
Anne M Beukers, MD, PhD contact
Anne M Beukers, MD, PhD study chair
Amsterdam UMC
David MP van Meenen, MD, PhD study chair
Amsterdam UMC
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 Cardiac Anaesthesia and Cardiac Surgery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Dec 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jord C Seegers, MD (+3120 566 9111, apecx@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: From date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.). The study lists 5 primary outcomes in all. 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 NCT07255924, which also lists 5 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 1 Dec 2025.