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RecruitingNCT07831252EadynUpdated Sep 21, 2026

The Relationship Between Hypotension and Tissue O2 in Invasive Eadyn During Anesthesia Induction in Open Heart Surgery

An observational study in Post-induction Hypotension, Eadyn and Cerebral and Kidney Regional Saturation, sponsored by Haseki Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Haseki Training and Research Hospital · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Post-induction Hypotension
  • Eadyn
  • Cerebral and Kidney Regional Saturation
  • Open Heart Surgery

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Keywords

  • Eadyn
  • post-induction hypotension
  • cerebral regional saturation
  • kidney regional saturation
03

In context

Hypotension

885 studies on the registry are indexed under Hypotension; 195 are open to participants now.

This study's planned enrollment of 40 is below the median of 90 across 265 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Haseki Training and Research Hospital is the lead sponsor of 78 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients diagnosed with coronary artery disease who were scheduled to undergo elective open-heart surgery were included in the study.

Eligibility criteria

Inclusion Criteria: • American Society of Anaesthesiologists (ASA) Physical Status classification I to III

  • Patients who planned open heart surgery

Exclusion Criteria: • Age \< 18 years

  • 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
  • Severe peripheral vascular disease
  • Morbid obesity
  • Emergency surgery cases
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

    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.

    Device: mostcare hemodynamic monitor · Device: Masimo NIRS · Device: Hemodynamic Measurements on Standart Monitoring

Interventions

  • Devicemostcare hemodynamic monitor

    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.

  • DeviceMasimo NIRS

    Cerebral and renal tissue oxygen saturation(rso2) values were measured using the Masimo device.

  • DeviceHemodynamic Measurements on Standart Monitoring

    Heart rate and peripheral oxygen saturation were measured using standard noninvasive monitoring.

06

What researchers measure

Primary outcomes

  1. Eadyn

    Dynamic Arterial Elastance

    Time frame: Perioperative

  2. rso2

    Cerebral and Kidney Regional Saturation

    Time frame: Perioperative

  3. Intraoperative hypotension

    Explanatory outcome

    Time frame: perioperative

07

Study locations

1 of 1 sites recruiting
  • Haseki Educational and Research Hospital
    Istanbul, Sultangazi 34270, Turkey (Türkiye)
    Recruiting
    • Muhammet A Gök, Medical Doctor · Contactdrmuhammetaligook@gmail.com · +9005393824171
    • Berna Çalışkan, Medical Doctor · Contactcaliskan.b@gmail.com · +9005067108770
    • Muhammet A Gök, Medical Doctor · Principal investigator
    • Berna Çalışkan, Medical Doctor · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.

Of 146 non-industry observational studies under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 15 months is above that.

Counting every sponsor, half of 151 studies reached it within 11 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 21, 2026
StartActual
Sep 1, 2025
Primary completionEst.
Dec 17, 2026
CompletionEst.
Dec 17, 2026
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07831252
Lead sponsor
Haseki Training and Research Hospital
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Sep 1, 2025
Primary completion
Dec 17, 2026 (estimated)
Completion
Dec 17, 2026 (estimated)
Last update
Sep 21, 2026

Study contacts

Muhammet A Gök, Medical Doctor
Contact
drmuhammetaligook@gmail.com
+9005393824171
Berna Çalışkan, Medical Doctor
study director · Haseki Educational and Research Hospital
Muhammet A Gök, Medical Doctor
principal investigator · Haseki Educational and Research Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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