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The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
**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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Fuzhou Hua, doctor
- Telefoonnummer: 15170238929
- E-mail: huafuzhou@126.com
Studie Locaties
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330000
- Werving
- Nanchang University Second Affiliated Hospital
-
Contact:
- Fuzhou Hua, doctor
- Telefoonnummer: 15170238929
- E-mail: huafuzhou@126.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Adult patients scheduled for elective cardiac surgery under general anesthesia
Beschrijving
Inclusion Criteria:
- Scheduled for elective cardiac surgery under general anesthesia;
- Aged ≥ 18 years, regardless of gender;
- NYHA cardiac function class < Ⅳ;
- ASA anesthesia class ≤ Ⅳ;
- Voluntarily sign the informed consent form.
Exclusion Criteria:
- History of mental or neurological diseases (including depression, severe central nervous system depression, schizophrenia, epilepsy, Parkinson's disease, Alzheimer's disease, etc.);
- Severe impairments that may hinder cognitive testing (such as blindness, severe deafness, or dementia);
- Preoperative use of psychotropic drugs or opioid drugs;
- 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);
- Previous cardiac surgery under general anesthesia;
- Missing perioperative data or postoperative loss to follow-up.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: OTHER
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
|---|
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative delirium incidence
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative pain score
Tijdsspanne: 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
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Ziekten van het zenuwstelsel
- Psychische aandoening
- Postoperatieve complicaties
- Pathologische processen
- Verwardheid
- Neurologische gedragsmanifestaties
- Neurocognitieve stoornissen
- Delirium
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Ontstaan Delirium
Andere studie-ID-nummers
- IIT-O-2025-394
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
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