Adıyaman University Training and Research Hospital
Adıyaman, Adıyaman Province, 02200, Turkey (Türkiye)
NCT Number: NCT07207421
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.
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All sexes
Interventional
Not applicable
Adıyaman, Adıyaman Province, 02200, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
General anesthesia for cardiac surgery followed by planned extubation in the operating room or within the first postoperative hour before ICU transfer.
Extubation will be targeted in the ICU according to respiratory effort.
Time frame: From the end of surgery (0 hour) up to 24 hours postoperatively, with hourly assessments
The Vaso-Inotropic Score (VIS) will be calculated hourly based on recorded inotrope and vasopressor infusion rates using the standard VIS calculation method. The primary outcome is the maximum (peak) VIS value observed during the first 24 postoperative hours. VIS values will be extracted from infusion charts and/or electronic medical records.
Time frame: 24 hour postoperatively
Assessed using the validated QoR-15 questionnaire to evaluate patient-reported recovery, including physical comfort, emotional state, and pain.
Time frame: Postoperative 2, 4, 6, 8, 12, and 24 hours (within the first 24 hours after surgery)
Visual Analog Scale (VAS); range: 0-10, where higher scores indicate worse pain.
Adiyaman University Research Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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