Intraoperative Dexmedetomidine Use and Postoperative Delirium After Cardiac Surgery

NCT07759297 | Completed

• 1 other identifier: TJ-IRB202603077
• Study Type: observational
• Target: 5,468
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate whether intraoperative dexmedetomidine use is associated with postoperative delirium in adults undergoing cardiac surgery. The study includes two linked components. First, researchers will analyze routinely collected clinical data from patients who underwent cardiac surgery at Tongji Hospital between January 2015 and December 2025. Second, archived plasma samples from a previously established observational cohort will be tested for matrix metalloproteinase-8 (MMP-8), a blood protein involved in inflammation and tissue injury. Researchers will compare patients who received dexmedetomidine during surgery with patients who did not receive dexmedetomidine. The decision to administer dexmedetomidine was made by the attending anesthesiologist based on the patient's clinical condition and routine anesthetic practice and was not assigned by the study protocol. The study will examine the associations among intraoperative dexmedetomidine use, perioperative changes in MMP-8, and postoperative delirium.

Conditions

Postoperative Delirium

Keywords

Cardiac Surgery; Dexmedetomidine; Cardiopulmonary Bypass; Matrix Metalloproteinase 8; MMP-8

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium

  The number and proportion of participants who experienced at least one episode of postoperative delirium. Postoperative delirium was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). A documented diagnosis of postoperative delirium in the medical record was accepted. When no explicit diagnosis was documented, two trained researchers independently reviewed postoperative medical and nursing records using standardized DSM-5 criteria, with disagreements resolved by a third researcher.

  From the end of surgery through postoperative day 7 or hospital discharge, whichever occurred first

Secondary Outcomes (2)

• Hospital Length of Stay

  From hospital admission through hospital discharge during the index hospitalization, an average of approximately 3 weeks.

• In-Hospital All-Cause Mortality

  From the end of surgery until death or hospital discharge, whichever occurred first, an average of approximately 3 weeks.

Other Outcomes (2)

• Plasma Matrix Metalloproteinase-8 Level at the End of Surgery

  At the end of surgery

• Plasma Matrix Metalloproteinase-8 Level at 24 Hours Postoperatively

  At 24 hours after surgery

Study Arms (2)

Intraoperative Dexmedetomidine Group

Patients undergoing cardiac surgery with cardiopulmonary bypass who received dexmedetomidine during surgery as part of routine anesthetic care. The decision to administer dexmedetomidine was made by the attending anesthesiologist based on the patient's clinical condition and routine anesthetic practice and was not assigned by the study protocol.

Drug: Dexmedetomidine

No Intraoperative Dexmedetomidine Group

Patients undergoing cardiac surgery with cardiopulmonary bypass who did not receive dexmedetomidine during surgery as part of routine anesthetic care.

Interventions

Dexmedetomidine DRUG

Documented intraoperative administration of dexmedetomidine during cardiac surgery with cardiopulmonary bypass. The decision to administer dexmedetomidine was made by the attending anesthesiologist based on the patient's clinical condition and routine anesthesia practice and was not assigned by the study protocol. No standardized dexmedetomidine dose, timing, or duration was assigned by the study protocol.

Intraoperative Dexmedetomidine Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults aged 18 to 80 years who underwent cardiac surgery with cardiopulmonary bypass at Tongji Hospital. The retrospective cohort was identified from the Tongji Hospital research data platform and included eligible patients treated between January 2015 and December 2025. The biomarker subcohort consisted of eligible participants from a previously established observational cohort for whom archived perioperative plasma samples and linked clinical data were available.

You may qualify if:

• Adults aged 18 to 80 years.
• Patients who underwent cardiac surgery with cardiopulmonary bypass at Tongji Hospital during the predefined study period.
• Availability of perioperative medication records and postoperative medical and nursing records sufficient to determine intraoperative dexmedetomidine exposure and postoperative delirium status.
• For the biomarker subcohort, availability of archived plasma samples collected preoperatively, at the end of surgery, and 24 hours postoperatively, together with linked clinical data.

You may not qualify if:

• Pregnancy.
• Inability to communicate effectively because of severe visual, auditory, or language impairment.
• Preoperative delirium or dementia.
• A history of severe psychiatric illness, including schizophrenia or severe depressive disorder.
• Long-term or high-dose use of antipsychotic medications.
• Intolerance or allergy to benzodiazepines.
• Myasthenia gravis.
• Acute stroke or severe traumatic brain injury within the preceding 6 months.
• Previous solid-organ or bone marrow transplantation.

Sponsors & Collaborators

• Shusheng Li: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Archived plasma samples collected preoperatively, at the end of surgery, and 24 hours postoperatively are retained at -80°C in the Department of Anesthesiology biobank for MMP-8 and related biomarker analyses.

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Qin Zhang

  Tongj Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 12, 2026
• Study Start: April 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: January 3, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)