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EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY

THE EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07817264
Enrollment
50
Registered
2026-09-14
Start date
2024-10-30
Completion date
2025-05-30
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ERAS Programmes

Keywords

ERAS, Postoperative Pain, Cardiac Surgery, Anxiety, Symptoms

Brief 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.

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.

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.

Sponsors

Karabuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

After confirming that the individuals met the inclusion and exclusion criteria, eligible participants were randomly assigned to either the Enhanced Recovery After Surgery (ERAS) group or the control group using a one-to-one allocation ratio. Each participant had an equal probability of being assigned to either group, and the allocation was independent of previous assignments. The sealed envelope method was used to determine whether participants would be assigned to the ERAS or control group. The ERAS group was coded as "0" and the control group as "1". When an eligible participant was identified, a person who was not involved in the study was presented with a set of mixed, sealed envelopes and asked to randomly select one envelope. The selected envelope was then opened to determine the group to which the participant would be assigned. This procedure was used to minimize selection bias by ensuring that group allocation was performed randomly and independently of the researcher.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 hemoglobin, 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 informed consent to participate in the study.

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery-40 (QoR-40) Scoreone monthThe 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

Secondary

MeasureTime frameDescription
Cardiac Surgery-Related Symptom Scoreone monthThe 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORAynur Ülkü

Karabuk Universty

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026