EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY

NCT07817264 | Completed

• 1 other identifier: KarabukU-AUlku-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

ERAS Programmes

Keywords

ERAS; Postoperative Pain; Cardiac Surgery; Anxiety; Symptoms

Outcome Measures

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

  one month

Secondary Outcomes (1)

• Cardiac Surgery-Related Symptom Score

  one month

Other Outcomes (2)

• State-Trait Anxiety Inventory Score

  1 month

• Postoperative Delirium

  One month

Study Arms (2)

ENHANCED RECOVERY AFTER SURGERY (ERAS) GROUP

EXPERIMENTAL

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

CONTROL GROUP

NO INTERVENTION

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

Enhanced Recovery After Surgery (ERAS) Protocol BEHAVIORAL

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.

ENHANCED RECOVERY AFTER SURGERY (ERAS) GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Interventions

Enhanced Recovery After Surgery; Clinical Protocols

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Aynur Ülkü

  Karabuk Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: October 30, 2024
• Primary Completion: October 30, 2024
• Study Completion: May 30, 2025
• Last Updated: September 14, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)