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

2026. november 2. frissítette: 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.

A tanulmány áttekintése

Állapot

Toborzás

Részletes leírás

**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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

320

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

    • Jiangxi
      • Nanchang, Jiangxi, Kína, 330000
        • Toborzás
        • Nanchang University Second Affiliated Hospital
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

Adult patients scheduled for elective cardiac surgery under general anesthesia

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Megfigyelési modellek: OTHER
  • Időperspektívák: PROSPECTIVE

Kohorszok és beavatkozások

Csoport / Kohorsz
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Postoperative delirium incidence
Időkeret: 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.

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Postoperative pain score
Időkeret: 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
Időkeret: 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.

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. január 1.

Elsődleges befejezés (Becsült)

2027. január 1.

A tanulmány befejezése (Becsült)

2027. január 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. január 17.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 2.

Első közzététel (Tényleges)

2026. november 6.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. november 6.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 2.

Utolsó ellenőrzés

2025. december 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

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.

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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