The Effect of Ultra-Fast-Track Cardiac Anesthesia in Coronary Artery Bypass Grafting Surgery

NCT ID: NCT07207421

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2025-12-31

Brief Summary

This randomized controlled trial aims to evaluate the impact of Ultra-Fast-Track (UFT) anesthesia on postoperative recovery in patients undergoing elective coronary artery bypass grafting (CABG). UFT anesthesia targets extubation in the operating room or within the first hour after surgery, whereas standard care involves transfer to the intensive care unit (ICU) with subsequent extubation according to routine protocols. A total of 100 patients will be randomized in a 1:1 ratio. The primary outcome is the maximum Vaso-Inotropic Score (VIS) within the first 24 postoperative hours. Secondary outcomes include postoperative pain scores (VAS), Quality of Recovery-15 (QoR-15) scores, opioid and analgesic requirements, ICU and hospital length of stay, time to mobilization, and postoperative complications. This study seeks to determine whether UFT anesthesia can safely reduce inotropic support requirements and enhance early recovery following CABG.

Detailed Description

Coronary artery bypass grafting (CABG) is the most frequently performed cardiac surgical procedure and remains the gold standard for the treatment of advanced coronary artery disease. While CABG restores myocardial perfusion and relieves ischemic symptoms, the postoperative period is often associated with prolonged mechanical ventilation, increased risk of complications, higher costs, and delayed recovery.

Ultra-Fast-Track (UFT) anesthesia is a perioperative strategy that aims to achieve extubation either in the operating room or within the first postoperative hour. Previous studies have demonstrated that fast-track and UFT protocols may shorten intensive care unit (ICU) length of stay, reduce postoperative complications, and improve recovery, without compromising patient safety. However, the influence of UFT anesthesia on inotropic support requirements, recovery quality, and analgesic needs in patients undergoing CABG has not been fully clarified.

In this prospective, randomized, controlled clinical trial, 100 patients scheduled for elective CABG will be randomly assigned to one of two groups:

UFT group: patients will undergo standard general anesthesia for cardiac surgery and will be extubated in the operating room or within one hour postoperatively before ICU transfer.

Standard care group: patients will undergo the same anesthesia protocol but will remain intubated upon ICU admission, with extubation performed according to routine ICU protocols.

The primary endpoint is the maximum Vaso-Inotropic Score (VIS) recorded during the first 24 hours after surgery. Secondary endpoints include postoperative pain scores (VAS), opioid and analgesic requirements, Quality of Recovery-15 (QoR-15) scores at 24 and 72 hours, ICU and hospital length of stay, time to mobilization, and the incidence of postoperative complications such as reintubation, pneumonia, atrial fibrillation, and acute kidney injury.

This study is designed to provide high-quality evidence on whether UFT anesthesia can safely decrease inotropic support requirements, enhance postoperative recovery, and reduce ICU stay in patients undergoing CABG.

Conditions

Coronary Artery Disease; Coronary Artery Bypass Graft (CABG)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Ultra-Fast-Track Anesthesia group

Patients will receive standard general anesthesia for cardiac surgery. Extubation will be targeted in the operating room or within the first postoperative hour before ICU transfer.

Group Type: EXPERIMENTAL

Ultra-Fast-Track Anesthesia

Intervention Type: PROCEDURE

General anesthesia for cardiac surgery followed by planned extubation in the operating room or within the first postoperative hour before ICU transfer.

Standard care group

Patients will receive standard general anesthesia for cardiac surgery. They will remain intubated upon ICU admission and will be extubated according to routine ICU protocols.

Group Type: ACTIVE_COMPARATOR

Standart care anesthesia

Intervention Type: PROCEDURE

Extubation will be targeted in the ICU according to respiratory effort.

Interventions

Ultra-Fast-Track Anesthesia

General anesthesia for cardiac surgery followed by planned extubation in the operating room or within the first postoperative hour before ICU transfer.

Intervention Type: PROCEDURE

Standart care anesthesia

Extubation will be targeted in the ICU according to respiratory effort.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults aged ≥18 years undergoing elective coronary artery bypass grafting (CABG)
• Patients suitable for Ultra-Fast-Track anesthesia as determined by the anesthesia team
• Ability to provide written informed consent

Exclusion Criteria

• Emergency CABG or combined cardiac procedures (e.g., valve surgery)
• Preoperative shock or requirement for mechanical ventilation
• Severe pulmonary disease (e.g., GOLD stage 3-4 COPD, home oxygen therapy)
• Severe hepatic failure or end-stage renal disease requiring dialysis
• Pregnancy
• Inability to provide informed consent or follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adiyaman University Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nezir Yılmaz

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

NEZİR YILMAZ, Associate Professor

Role: CONTACT

yilmaznezir@hotmail.com

+905068939496

Other Identifiers

ADYU-ANS-NY-012

Identifier Type: -

Identifier Source: org_study_id