An observational study in Delirium - Postoperative and Cardiac Surgery, sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Second Affiliated Hospital of Nanchang University · Observational
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.
**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.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's planned enrollment of 320 is above the median of 162 across 279 observational studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Second Affiliated Hospital of Nanchang University is the lead sponsor of 85 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients scheduled for elective cardiac surgery under general anesthesia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The duration of endotracheal tube placement after surgery was less than or equal to six hours.
The duration of endotracheal tube placement after surgery exceeds six hours.
Postoperative delirium incidence
Postoperative visits were conducted to assess the patient's delirium status using professional scales, for a duration of seven days or until discharge.
Time frame: Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.
Postoperative pain score
Postoperative visits were conducted to assess the patient's pain status using professional scales, for a duration of seven days or until discharge.
Time frame: Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.
Intraoperative and postoperative opioid dosage
Time frame: Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.
Of 181 non-industry observational studies under Emergence Delirium, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 12 months is below that.
Counting every sponsor, half of 181 studies reached it within 21 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Second Affiliated Hospital of Nanchang University