ClinicalTrials.gg
CompletedNCT07817264Updated Sep 14, 2026

EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY

An interventional study of Enhanced Recovery After Surgery (ERAS) Protocol in ERAS Programmes, sponsored by Karabuk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Karabuk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Oct 2024, registered Sep 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,093 studies in Pain, Postoperative with a site in Turkey — 262 open to participants now, 294 under way, none of them phase 3. Pain, Postoperative · Turkey.

Enrollment
728th of 878
50 · median 70
Started
2024
with 150 others
No phase
809 of 1,093
215 open now
Registered
1,031st of 1,093
by date

Among the 1,093 studies in Pain, Postoperative with a site in Turkey, this one is the 728th largest by enrollment of the 878 interventional ones that give a count, is one of 151 that started in 2024, is one of 809 with no phase, and was the 1,031st registered.

Pain, Postoperative

5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

262 of the 1,093 studies in Pain, Postoperative with a site in Turkey are open now. Recruiting first, the newest first:

257 more — sign in →

All 262 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

A randomized controlled experimental study has been conducted to determine the effects of Enhanced Recovery After Surgery (ERAS) protocols on patient outcomes in the Cardiovascular Surgery Clinic.

Read the detailed description

This randomized controlled trial was conducted to evaluate the effects of an Enhanced Recovery After Surgery (ERAS) protocol on postoperative recovery and patient outcomes in patients undergoing elective coronary artery bypass grafting (CABG) surgery. The study was conducted in the Cardiovascular Surgery Clinic of Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital. A total of 50 patients who met the eligibility criteria were included in the study and randomly assigned to either the ERAS group (n=25) or the control group (n=25). Patients in the ERAS group received a comprehensive perioperative care program based on ERAS principles. The ERAS program included preoperative oral carbohydrate loading, multimodal analgesia, prevention of postoperative nausea and vomiting, early extubation, respiratory exercises, coughing exercises, early mobilization, and other evidence-based perioperative interventions. Patients in the control group received routine perioperative care according to standard clinical practice. The primary outcomes included quality of recovery and postoperative clinical outcomes. Quality of recovery was assessed using the Quality of Recovery-40 (QoR-40) questionnaire. Secondary outcomes included anxiety, pain intensity, nutritional risk, postoperative delirium, and cardiovascular surgery-related symptoms. Clinical recovery outcomes included time to extubation, duration of intensive care unit stay, duration of surgical drain use, time to urinary catheter removal, time to first bowel movement, time to first oral intake, and length of hospital stay. Patients were evaluated at multiple time points throughout the postoperative recovery process. Assessments were performed during the intensive care unit stay, after transfer to the surgical ward, at hospital discharge, and at one week and one month after discharge. These repeated assessments were used to evaluate changes in quality of recovery, anxiety, pain, cardiovascular surgery-related symptoms, and other patient outcomes over time. The study aimed to determine whether implementation of a comprehensive ERAS protocol could improve quality of recovery, reduce postoperative symptoms and anxiety, facilitate earlier recovery, shorten intensive care unit and hospital stays, and contribute to improved clinical outcomes in patients undergoing cardiovascular surgery.

03

Conditions studied

  • ERAS Programmes

Keywords

  • ERAS
  • Postoperative Pain
  • Cardiac Surgery
  • Anxiety
  • Symptoms
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being admitted for their first planned coronary artery bypass graft (CABG) surgery;
  • Undergoing off-pump coronary artery bypass (OPCAB) surgery without the use of a cardiopulmonary bypass machine;
  • Not undergoing any additional surgical procedure during CABG surgery;
  • Having no abnormalities in preoperative laboratory parameters, including , albumin, and electrolytes;
  • Having no cognitive impairment;
  • Having no psychological or mental disorder;
  • Being able to speak Turkish and communicate effectively;
  • Being at least literate;
  • Being 18 years of age or older;
  • Being reachable by telephone during the follow-up period; and
  • Providing to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Having previously undergone CABG surgery;
  • Undergoing CABG surgery using cardiopulmonary bypass with the heart arrested;
  • Undergoing any additional surgical procedure during CABG surgery;
  • Having electrolyte abnormalities in preoperative laboratory parameters;
  • Having cognitive impairment;
  • Having a psychological or mental disorder;
  • Being unable to speak Turkish, communicate effectively, or provide consent to participate in the study;
  • Being unable to read and write;
  • Being younger than 18 years of age;
  • Being unreachable by telephone during the follow-up period;
  • Withdrawing from the study after initially agreeing to participate;
  • Undergoing any surgical operation after hospital admission; or
  • Dying during the study intervention or follow-up period.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    ENHANCED RECOVERY AFTER SURGERY (ERAS) GROUP

    Patients in the ERAS group received a multimodal enhanced recovery program covering the preoperative, intraoperative, and postoperative periods. Interventions included patient education and counseling, nutritional assessment and support when indicated, preoperative oral carbohydrate loading, appropriate fasting, and avoidance of mechanical bowel preparation. Intraoperative interventions included multimodal anesthesia, lung-protective ventilation, maintenance of normothermia, antimicrobial prophylaxis, blood conservation, and minimization of surgical drains. Postoperative care included early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, multimodal analgesia, thromboprophylaxis, glycemic control, wound care, delirium screening, and early removal of chest tubes and urinary catheters when clinically appropriate. Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed during

    Behavioral: Enhanced Recovery After Surgery (ERAS) Protocol

  • No intervention
    CONTROL GROUP

    Patients in the control group received routine perioperative care according to standard clinical practice. No specific Enhanced Recovery After Surgery (ERAS) protocol was applied. Patients received standard preoperative, intraoperative, and postoperative care, including routine monitoring, pain management, respiratory care, mobilization, nutritional management, and other clinical interventions as indicated by the treating healthcare team. Patient outcomes were assessed at the same time points as in the ERAS group.

Interventions

  • BehavioralEnhanced Recovery After Surgery (ERAS) Protocol

    A comprehensive 31-factor Enhanced Recovery After Surgery (ERAS) program was implemented throughout the perioperative period in patients undergoing elective coronary artery bypass grafting (CABG) surgery. The program included patient education and counseling, nutritional assessment, preoperative oral carbohydrate loading, appropriate fasting, avoidance of mechanical bowel preparation, multimodal anesthesia and analgesia, lung-protective ventilation, normothermia, antimicrobial prophylaxis, blood conservation, prevention of postoperative nausea and vomiting, early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, thromboprophylaxis, glycemic control, systematic delirium screening, wound care, and early removal of chest tubes and urinary catheters when clinically appropriate. Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed at predefined postoperative time points.

06

What researchers measure

Primary outcomes

  1. Quality of Recovery-40 (QoR-40) Score

    The scale is a 5-point Likert-type scale, and the total score ranges from 40 to 200 based on the sum of all items. A higher total score indicates that the patients' emotional and physical well-being is at the expected and favorable level following surgery, whereas a lower score indicates that their well-being has been adversely affected. With a Cronbach's alpha value of 0.936, the questionnaire is a valid and reliable instrument for assessing recovery following

    Time frame: one month

Secondary outcomes

  1. Cardiac Surgery-Related Symptom Score

    The inventory is unidimensional and consists of 35 items. It is a Likert-type instrument, with each item scored from 0 to 4. The total score ranges from 0 to 140, with higher scores indicating greater symptom severity. The inventory has a total Cronbach's alpha coefficient of 0.961, and the total item correlations for all items are positive.

    Time frame: one month

Other outcomes

  1. State-Trait Anxiety Inventory Score

    The State-Trait Anxiety Inventory (STAI) was developed to assess individuals' state and trait anxiety levels separately. The scale consists of two sections and 40 items. The first section, the State Anxiety Inventory, assesses how the individual feels at a particular moment, whereas the second section, the Trait Anxiety Inventory, assesses the individual's general feelings and anxiety tendency. Higher total anxiety scores indicate higher levels of anxiety. The scale has a Cronbach's alpha coefficient of 0.76.

    Time frame: 1 month

  2. Postoperative Delirium

    The scale assesses eight domains: attention deficit, altered level of consciousness, hallucinations, psychosis, delusions, disorientation, psychomotor retardation or agitation, inappropriate affect or speech, sleep-wake cycle disturbance, and fluctuating course of symptoms. Negative findings are scored as 0, while positive findings are scored as 1. Patients with a total score of 4 or higher are considered to have delirium

    Time frame: One month

07

Study locations

1 site
  • Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital
    Bolu, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant-level data will not be shared publicly due to patient privacy and confidentiality requirements. However, the aggregated results of the study will be reported and made available through scientific publication. No personally identifiable patient information will be included in the published results.

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

Ran from Oct 2024 to primary completion in Oct 2024, 0 months.

Of 2,094 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 0 months is below that.

Counting every sponsor, half of 2,107 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

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

Registered
Sep 8, 2026
First posted
Sep 14, 2026
StartActual
Oct 30, 2024
Primary completionActual
Oct 30, 2024
CompletionActual
May 30, 2025
Last update
Sep 14, 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 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07817264
Lead sponsor
Karabuk University
Responsible party
Aynur Ülkü (Assistant Professor, Karabuk University) — Principal investigator
First posted
Sep 14, 2026
Start date
Oct 30, 2024
Primary completion
Oct 30, 2024
Completion
May 30, 2025
Last update
Sep 14, 2026

Study contacts

Aynur Ülkü
principal investigator · Karabuk Universty

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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