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The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery

2026年11月2日 更新者:Fuzhou Hua、Second Affiliated Hospital of Nanchang University

The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery: A Prospective Cohort Study Basic Information

Postoperative delirium (POD) is a common complication following cardiac surgery and is associated with prolonged intensive care unit (ICU) stay, increased healthcare costs, and adverse clinical outcomes. Fast-track anesthesia aims to facilitate early postoperative extubation and recovery; however, its association with postoperative neurocognitive outcomes remains uncertain.

This single-center, prospective observational cohort study aims to compare the incidence of postoperative delirium between patients undergoing fast-track and conventional postoperative anesthetic management following elective cardiac surgery. The study will be conducted at the Second Affiliated Hospital of Nanchang University from January 2026 to January 2027. A total of 320 adult patients are planned to be enrolled, including 130 in the fast-track group and 190 in the control group.

Patients will be categorized according to the duration of postoperative endotracheal intubation. The fast-track group will include patients extubated within 6 hours after surgery, while the control group will include patients extubated more than 6 hours after surgery. Anesthesia and postoperative care will follow routine clinical practice without study-mandated interventions. The primary outcome is the incidence of postoperative delirium, assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the 3-Minute Diagnostic Interview for Delirium (3D-CAM) from postoperative day 1 through day 7 or until hospital discharge, whichever occurs first.

研究概览

地位

招聘中

详细说明

**Background and Rationale**

Postoperative delirium (POD) is a frequent neurological complication following cardiac surgery. It is characterized by acute and fluctuating disturbances in attention, awareness, and cognitive function. POD is associated with prolonged intensive care unit (ICU) stay, increased hospitalization costs, and unfavorable postoperative outcomes.

Fast-track anesthesia is a perioperative management strategy intended to facilitate early extubation and postoperative recovery after cardiac surgery. Although early extubation may reduce the duration of mechanical ventilation and ICU stay, its association with postoperative delirium remains uncertain. This study aims to investigate the relationship between fast-track anesthesia, postoperative extubation timing, and delirium in adult cardiac surgery patients.

**Study Design and Setting**

This is a single-center, prospective observational cohort study conducted at the Second Affiliated Hospital of Nanchang University, China. The planned study period is January 2026 to January 2027, with a target enrollment of 320 adult patients undergoing elective cardiac surgery under general anesthesia.

The study does not assign patients to specific anesthetic interventions. All anesthetic management decisions are made by the attending anesthesiologists according to routine clinical practice and individual patient characteristics.

**Exposure Classification**

Patients will be classified into two observational cohorts according to the duration of postoperative endotracheal intubation, measured from the end of surgery to the first successful extubation.

The fast-track group will consist of patients extubated within 6 hours after surgery, whereas the control group will consist of patients extubated more than 6 hours after surgery.

Postoperative extubation readiness will be assessed by ICU physicians based on the patient's consciousness, respiratory function, hemodynamic stability, and relevant laboratory findings. Extubation decisions will follow routine clinical practice rather than study-assigned procedures.

**Perioperative Management**

All patients will receive general anesthesia for elective cardiac surgery. Anesthetic induction and maintenance will be individualized by the attending anesthesiologist using routinely available intravenous and inhalational anesthetic agents.

Intraoperative monitoring will include standard hemodynamic monitoring and bispectral index (BIS) monitoring. For patients requiring cardiopulmonary bypass, additional monitoring and anesthetic adjustments will be performed according to clinical requirements.

Postoperative pain management will include multimodal analgesia according to routine institutional practice. The study will not require additional anesthetic medications or invasive procedures beyond standard clinical care.

**Postoperative Assessment**

Patients will undergo postoperative follow-up for up to 7 days. Postoperative delirium will be evaluated using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the 3-Minute Diagnostic Interview for Delirium (3D-CAM), as appropriate.

Delirium assessments will begin on postoperative day 1 and continue through postoperative day 7 or until hospital discharge, whichever occurs first. For patients discharged before postoperative day 7, a final assessment will be performed within 24 hours before discharge. Additional assessments will be conducted when symptoms suggestive of delirium are observed.

Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS). Perioperative clinical data will be collected from medical records and postoperative assessments.

**Statistical Analysis**

The primary analysis will compare the incidence of postoperative delirium between the fast-track and control groups. Delirium incidence will be calculated as the proportion of patients experiencing postoperative delirium during the observation period.

Categorical variables will be summarized as frequencies and percentages and compared using the chi-square test or Fisher's exact test, as appropriate. Continuous variables will be summarized according to their distributions and compared using parametric or nonparametric statistical tests.

Statistical analyses will be performed using GraphPad Prism 8. A two-sided P-value of less than 0.05 will be considered statistically significant.

研究类型

观察性的

注册 (估计的)

320

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Jiangxi
      • Nanchang、Jiangxi、中国、330000
        • 招聘中
        • Nanchang University Second Affiliated Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult patients scheduled for elective cardiac surgery under general anesthesia

描述

Inclusion Criteria:

  1. Scheduled for elective cardiac surgery under general anesthesia;
  2. Aged ≥ 18 years, regardless of gender;
  3. NYHA cardiac function class < Ⅳ;
  4. ASA anesthesia class ≤ Ⅳ;
  5. Voluntarily sign the informed consent form.

Exclusion Criteria:

  1. History of mental or neurological diseases (including depression, severe central nervous system depression, schizophrenia, epilepsy, Parkinson's disease, Alzheimer's disease, etc.);
  2. Severe impairments that may hinder cognitive testing (such as blindness, severe deafness, or dementia);
  3. Preoperative use of psychotropic drugs or opioid drugs;
  4. Relative contraindications to general anesthesia: patients with severe pulmonary dysfunction, severe hepatic or renal dysfunction, severe infection, uncontrolled hypertension, diabetes mellitus, or severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular diseases, diabetic nephropathy);
  5. Previous cardiac surgery under general anesthesia;
  6. Missing perioperative data or postoperative loss to follow-up.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:OTHER
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
fast-track group

The duration of endotracheal tube placement after surgery was less than or equal to six hours.

control group

The duration of endotracheal tube placement after surgery exceeds six hours.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Postoperative delirium incidence
大体时间:Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.

Postoperative visits were conducted to assess the patient's delirium status using professional scales, for a duration of seven days or until discharge.

Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.

次要结果测量

结果测量
措施说明
大体时间
Postoperative pain score
大体时间:Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.

Postoperative visits were conducted to assess the patient's pain status using professional scales, for a duration of seven days or until discharge.

Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.
Intraoperative and postoperative opioid dosage
大体时间:Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.
Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年1月17日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2025年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

The data of this study are derived from the hospital's internal electronic medical record system and inpatient management system, including patients' demographic information, clinical diagnosis and treatment details, intraoperative anesthesia records, postoperative follow-up data, and other sensitive content closely related to patient privacy. In accordance with medical ethics requirements, relevant laws and regulations on personal information protection, and the confidentiality statement specified in the study protocol, to ensure the security of patient privacy and avoid potential risks of information leakage, the research data are not suitable for sharing with external parties or irrelevant personnel without the written approval of the principal investigator and the review and consent of the Ethics Committee.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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