Post-induction HypotensionEadynNCT07831252
The Relationship Between Hypotension and Tissue O2 in Invasive Eadyn During Anesthesia Induction in Open Heart Surgery
An observational study of Post-induction Hypotension and Eadyn, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Our aim is to identify patients who may experience hypotension during anesthesia induction. Intraoperative hemodynamic stability plays an important role in tissue oxygenation. Although the duration of hypotension can be kept short with the necessary interventions, it is important that hypotension is predictable in… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post-induction Hypotension, Eadyn, Cerebral and Kidney Regional Saturation
- What is being tested?
- mostcare hemodynamic monitor, Masimo NIRS and Hemodynamic Measurements on Standart Monitoring
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 17 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with coronary artery disease who were scheduled to undergo elective open-heart surgery were included in the study.
Who may be able to join
None listed.
Who cannot join
- Presence of arrhythmia (atrial fibrillation or frequent premature beats)
- Severe valvular heart disease (aortic or mitral stenosis/insufficiency)
- Severe heart failure (EF < 40%)
- Congenital heart disease
- Severe chronic lung disease
- Chronic kidney disease requiring dialysis
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- Severe peripheral vascular disease
- Morbid obesity
- Emergency surgery cases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Haseki Educational and Research Hospital
Istanbul, Sultangazi, 34270
Muhammet A Gök, Medical Doctor, +9005393824171, drmuhammetaligook@gmail.com
Berna Çalışkan, Medical Doctor, +9005067108770, caliskan.b@gmail.com
About this study
Official title: Investigation of the Relationship Between Hypotension and Tissue O2 in Invasive Eadyn During Anesthesia Induction in Open Heart Surgery: Observational Study
Our aim is to identify patients who may experience hypotension during anesthesia induction. Intraoperative hemodynamic stability plays an important role in tissue oxygenation. Although the duration of hypotension can be kept short with the necessary interventions, it is important that hypotension is predictable in order to prevent intraoperative complications and postoperative organ damage.
40 patients scheduled for open heart surgery will be monitored from one minute before anesthesia is administered until ten minutes after. Patients will be divided into two groups based on the presence or absence of hypotension during the monitoring period. All patients will be monitored according to a standardized procedure. Demographic data, non-invasive and invasive hemodynamic parameters, primarily Eadyn, and cerebral and renal tissue saturation data will be collected. Moreover, vasopressor administration in response to hypotension will be recorded.
Read the detailed description
Introduction: Hypotension during and after the induction of anesthesia is a common occurrence. Several factors may contribute to post-induction hypotension, including prolonged fasting, underlying comorbidities, sympathetic blockade induced by anesthetic agents, vasodilation, decreased preload, and reduced cardiac contractility.
Numerous studies have identified factors and predictors associated with post-induction hypotension; however, most of these predictors are non-modifiable. Previous research has shown that patients at risk for post-induction hypotension can be identified using variables such as the inferior vena cava collapsibility index, carotid intima-media thickness, pulse pressure variation (PPV), and stroke volume variation (SVV).
Nevertheless, most of these studies have focused on assessing the cardiovascular system using preload- and fluid-responsiveness-related parameters, while the interaction between the arterial system and the ventricle has often been overlooked. Dynamic arterial elastance (Eadyn), defined as the ratio between pulse pressure variation (PPV) and stroke volume variation (SVV), integrates the flow generated by the heart and the opposing pressure from the arterial system during the respiratory cycle, and has been proposed as a functional measure of arterial load.
Furthermore, recent studies suggest that post-induction hypotension is associated with arterial vasodilation rather than venous dilation or decreased myocardial contractility.
In current anesthetic practice, interventions are typically applied only after hypotension has developed. We hypothesize that if patients at risk of developing hypotension during anesthesia induction can be identified in advance, prophylactic administration of fluids and vasopressors could reduce the duration and severity of hypotension, thereby preventing potential intraoperative complications and postoperative organ dysfunction.
Material method: Patients scheduled for open heart surgery after October 17, 2025, are eligible for this study after ethical board approval. Inclusion criterions are (1) patients aged between 18-90 years with American Society of Anaesthesiologists (ASA) Physical Status classification I to III, (2)planned open heart surgery. Written informed consent will be obtained from all participants.
Exclusion criteria are refusal to participate in the study, younger than 18 years of age; those with arrhythmias (including atrial fibrillation or frequent premature beats); severe valvular heart disease (aortic or mitral stenosis or insufficiency); severe heart failure (ejection fraction < 40%); congenital heart disease; pre-existing severe pulmonary disease; chronic kidney disease requiring dialysis; severe peripheral vascular disease; morbid obesity; and patients undergoing emergency surgery.
All patients received standard general anesthesia with monitoring that included Masimo SedLine -NIRS(noninvasive regional saturation), Mostcare invasive hemodynamic monitoring, and conventional standard monitors; Anesthesia induction was performed with midazolam (0.025 mg/kg), propofol (1.5-2.5 mg/kg), lidocaine (1 mg/kg), and rocuronium (1 mg/kg). Anesthetics and opioid administration was titrated according to hemodynamic parameters and Patient State Index (PSI) values between 25 and 50.
For each patient, both the total cumulative dose of ephedrine administered and the number of times it was given were recorded.
- Conditions
- Post-induction Hypotension, Eadyn, Cerebral and Kidney Regional Saturation, Open Heart Surgery
- Being tested
- mostcare hemodynamic monitor, Masimo NIRS, Hemodynamic Measurements on Standart Monitoring
- Keywords
- Eadyn, post-induction hypotension, cerebral regional saturation, kidney regional saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mostcare hemodynamic monitorDevice
Invasive hemodynamic variables including dynamic arterial elastance (Eadyn), stroke volume variation (SVV), pulse pressure variation (PPV), cardiac index (CI), oxygen delivery (DO₂), and cardiac power output (CPO) were obtained using the MostCare monitor.
Masimo NIRSDevice
Cerebral and renal tissue oxygen saturation(rso2) values were measured using the Masimo device.
Hemodynamic Measurements on Standart MonitoringDevice
Heart rate and peripheral oxygen saturation were measured using standard noninvasive monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Hypotension Group | Patients whose systolic blood pressure decreased below 90 mmHg or whose mean arterial pressure dropped by more than 30% from the preinduction baseline value were classified as hypotensive Receives: Device: mostcare hemodynamic monitor; Device: Masimo NIRS; Device: Hemodynamic Measurements on Standart Monitoring | |
| Non-hypotension Group | Patients whose systolic blood pressure remained above 90 mmHg and whose mean arterial pressure did not decrease by more than 30% from the preinduction baseline value were classified as non-hypotensive. Receives: Device: mostcare hemodynamic monitor; Device: Masimo NIRS; Device: Hemodynamic Measurements on Standart Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eadyn
Dynamic Arterial Elastance
Measured: Perioperative
rso2
Cerebral and Kidney Regional Saturation
Measured: Perioperative
Intraoperative hypotension
Explanatory outcome
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Sep 2025
- Primary completion17 Dec 2026 (estimated)
- Study completion17 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-induction HypotensionStudies of the same condition, open and under way.
- 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 (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Çalışkan, Medical Doctor, Study director, Haseki Educational and Research HospitalMuhammet A Gök, Medical Doctor, Principal investigator, Haseki Educational and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831252
- Sponsor's protocol ID
- 212-2025
- Acronym
- Eadyn
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No