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临床试验/NCT07207421
NCT07207421已完成不适用

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

Adiyaman University Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Vaso-Inotropic Score (VIS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Ultra-Fast-Track Anesthesia group

Experimental

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.

干预措施: Ultra-Fast-Track Anesthesia (Procedure)

Standard care group

Active Comparator

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.

干预措施: Standart care anesthesia (Procedure)

结局指标

主要结局

Vaso-Inotropic Score (VIS)

时间窗: 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.

次要结局

  • Quality of Recovery (QoR-15) score(24 hour postoperatively)
  • Postoperative pain score (VAS)(Postoperative 2, 4, 6, 8, 12, and 24 hours (within the first 24 hours after surgery))

研究者

发起方
Adiyaman University Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nezir Yılmaz

Assoc. Prof.

Adiyaman University Research Hospital

研究点 (1)

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