Perioperative Dexmedetomidine and 30-Day Outcomes After Adult Cardiac Surgery

NCT07249164 | Completed

• 1 other identifier: CMUH114-REC3-181
• Study Type: observational
• Target: 408,153
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study uses de-identified electronic health record data from the TriNetX Global Collaborative Network (2010-01-01 to 2025-07-01) to examine whether perioperative dexmedetomidine (DEX) is associated with 30-day outcomes after adult cardiac surgery. Adults aged 18-100 years undergoing first-time coronary artery bypass grafting or heart valve surgery are included. Exposure is any DEX administration from 24 hours before to 48 hours after the index operation; comparators receive no DEX in this window. The primary outcome is delirium within 30 days. Secondary outcomes are 30-day all-cause mortality, acute kidney injury, pneumonia, sepsis, red blood cell transfusion/major bleeding, myocardial infarction, ischemic stroke/transient ischemic attack, atrial fibrillation, mechanical ventilation \>96 hours (days 4-30), and 30-day readmission (days 1-30). No treatments are assigned by investigators and no identifiable information is used. Findings aim to inform perioperative sedation strategies in routine cardiac surgery care.

Conditions

Delirium - Postoperative; Cardiac Surgical Procedures; Coronary Artery Bypass Graft (CABG); Valve Surgery; Postoperative Complications

Keywords

Dexmedetomidine; Perioperative Care; Cardiac Surgery; Propensity Score Matching; TriNetX

Outcome Measures

Primary Outcomes (1)

• Delirium within 30 days

  Delirium identified from EHR codes (ICD-10-CM/SNOMED CT). TriNetX "exclude prior to window" enabled; patients with delirium before Day 0 excluded from the risk set. Estimates reported as cumulative incidence and Cox HR with 95% CI.

  Day 0 through Day 30 after index surgery

Secondary Outcomes (10)

• All-cause mortality within 30 days

  Day 0 through Day 30 after index surgery

• Acute kidney injury within 30 days

  Day 0 through Day 30 after index surgery

• Pneumonia within 30 days

  Day 0 through Day 30 after index surgery

• Sepsis within 30 days

  Day 0 through Day 30 after index surgery

• Red blood cell transfusion or major haemorrhage within 30 days

  Day 0 through Day 30 after index surgery

Study Arms (2)

Perioperative Dexmedetomidine

Adults undergoing first-time CABG or valve surgery with any dexmedetomidine recorded from 24 h before to 48 h after the index surgery on TriNetX; exposure observed in routine care, not assigned by investigators.

Drug: Dexmedetomidine

No Perioperative Dexmedetomidine

Same surgical cohort with no dexmedetomidine recorded within the -24 to +48 h window; use of dexmedetomidine outside this window allowed; comparison reflects perioperative sedation strategy.

Other: Usual care without perioperative dexmedetomidine

Interventions

Dexmedetomidine DRUG

Exposure in routine care within -24 to +48 hours of the index cardiac surgery; dose and regimen not protocol-assigned; observational only; exposure captured from medication records and used to define the dexmedetomidine cohort.

Also known as: Precedex

Perioperative Dexmedetomidine

Usual care without perioperative dexmedetomidine OTHER

No dexmedetomidine administered within -24 to +48 hours of the index surgery; all other management per routine care; observational comparator; dexmedetomidine use outside this window permitted.

No Perioperative Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18-100 years undergoing first-time CABG or valve surgery in the TriNetX Global Collaborative Network (2010-01-01 to 2025-07-01); de-identified EHR data; exposure defined as perioperative dexmedetomidine -24 to +48 h; comparator without dexmedetomidine in that window.

You may qualify if:

• Age 18-100 years.
• First-time CABG or heart valve surgery within TriNetX during 2010-01-01 to 2025-07-01.
• ≥90 days pre-operative observable data and a 30-day post-operative window (death ≤30 days counts as complete).
• Index surgery, exposure window (-24 to +48 h), and outcomes identifiable from standardized platform codes/fields.

You may not qualify if:

• End-stage renal disease or dialysis within 90 days before index surgery (ICD-10-CM N18.6, Z49, Z99.2).
• Not first-time CABG/valve in the same admission.
• Missing required fields or conflicting records preventing unique case definition.
• Unable to confirm exposure window or outcomes within the platform.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taichung City, 40447, Taiwan

Location

Related Publications (3)

• Caetano da Silva L, Tapioca V, Viana P, Pereira EM, Gibicoski T, Amaral S. Dexmedetomidine for delirium prevention after cardiac surgery: An updated systematic review and meta-analysis with trial sequential analysis. Anaesth Crit Care Pain Med. 2025 Sep;44(5):101578. doi: 10.1016/j.accpm.2025.101578. Epub 2025 Jun 24.

  PMID: 40570954 BACKGROUND

• Wang HB, Jia Y, Zhang CB, Zhang L, Li YN, Ding J, Wu X, Zhang Z, Wang JH, Wang Y, Yan FX, Yuan S, Sessler DI. A randomised controlled trial of dexmedetomidine for delirium in adults undergoing heart valve surgery. Anaesthesia. 2023 May;78(5):571-576. doi: 10.1111/anae.15983. Epub 2023 Feb 16.

  PMID: 36794600 BACKGROUND

• Poon WH, Ling RR, Yang IX, Luo H, Kofidis T, MacLaren G, Tham C, Teoh KLK, Ramanathan K. Dexmedetomidine for adult cardiac surgery: a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2023 Mar;78(3):371-380. doi: 10.1111/anae.15947. Epub 2022 Dec 19.

  PMID: 36535747 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Postoperative Complications

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; 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

• En-Bo Wu, MD

  Department of Anesthesiology, China Medical University Hospital, Taichung City, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 25, 2025
• Study Start: January 1, 2010
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)