Perioperative Dexmedetomidine and 30-Day Outcomes After Adult Cardiac Surgery

China Medical University

Status: Completed

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

Treatments: Drug: Dexmedetomidine; Other: Usual care without perioperative dexmedetomidine

Study type: Observational

Funder types: Other

Identifiers

NCT07249164

CMUH114-REC3-181

Details and patient eligibility

About

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.

Full description

This is a retrospective cohort study using de-identified data from the TriNetX Global Collaborative Network (2010-01-01 to 2025-07-01). Adults aged 18-100 years undergoing first-time coronary artery bypass grafting or heart valve surgery will be identified. Perioperative exposure is defined as any dexmedetomidine administration from 24 hours before to 48 hours after the index surgery; the comparison cohort consists of patients without dexmedetomidine in this window. Clinical outcomes within 30 days after surgery include delirium as the primary outcome and a range of major postoperative complications and mortality. Propensity scores based on demographics, comorbidities, baseline medications and laboratory tests will be used to match or adjust between exposure groups, with balance assessed using standardized mean differences. Time-to-event analyses will use Cox proportional hazards models and Kaplan-Meier curves, with multiplicity controlled using the Benjamini-Hochberg false discovery rate. All analyses use only de-identified data within the TriNetX platform, with no direct contact with patients or access to identifiers.

Enrollment: 408,153 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

408,153 participants in 2 patient groups

Perioperative Dexmedetomidine

Description:

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.

Treatment:

Drug: Dexmedetomidine

No Perioperative Dexmedetomidine

Description:

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.

Treatment:

Other: Usual care without perioperative dexmedetomidine