Delirium - PostoperativeNCT07923344
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
An observational study of Delirium - Postoperative and Cardiac Surgery, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium - Postoperative, Cardiac Surgery
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective cardiac surgery under general anesthesia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanchang University Second Affiliated Hospital
Nanchang, Jiangxi, 330000
Fuzhou Hua, doctor, 15170238929, huafuzhou@126.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Delirium - Postoperative, Cardiac Surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.
Secondary outcomes (2)
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.
Measured: Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.
Intraoperative and postoperative opioid dosage
Measured: Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuzhou Hua, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923344
- Sponsor's protocol ID
- IIT-O-2025-394
- Status last verified
- Dec 2025
- First submitted
- 17 Jan 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery: A Prospective Cohort Study Basic Information
- ClinicalTrials.gov ID
- NCT07923344
- Acronym / sponsor ID
- IIT-O-2025-394
- Conditions
- Delirium - Postoperative, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective cardiac surgery under general anesthesia
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative delirium incidence
Time frame: 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.
2 secondary outcomes
Postoperative pain score
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium - Postoperative and Cardiac Surgery, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuzhou Hua, doctor (15170238929, huafuzhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium incidence (time frame: Postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.