Dexmedetomidine Medication Records and Delirium After Coronary Artery Bypass Grafting

NCT07249164 | Completed

• 1 other identifier: CMUH114-REC3-181
• Study Type: observational
• Target: 343,112
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective observational study uses de-identified electronic health records from the TriNetX Global Collaborative Network. The procedure eligibility period is 1 January 2010 through 1 July 2025. The primary analysis concerns adults with a recorded qualifying coronary artery bypass grafting (CABG) procedure. Valve-coded procedures are examined in a separately constructed and separately matched exploratory population. The populations may overlap and do not constitute independent replication cohorts. Patients are classified by the presence or absence of a dexmedetomidine medication record on the calendar day before or the day of the index procedure. This definition does not confirm administration, dose or intraday timing. The primary outcome is a qualifying delirium or disorientation code during days 1-30. Nine secondary endpoints concern mortality and selected recorded complications during days 0-30; eight are inferential and the prolonged-ventilation code endpoint is descriptive. An inpatient or observation encounter during days 1-30 is described separately and is not interpreted as readmission. Same-day records cannot establish whether an outcome preceded or followed exposure. No treatment is assigned by the investigators. Analyses use permitted aggregate outputs, without identifiable or row-level participant data. The clinical definitions were revised with knowledge of earlier analyses. CABG primary and F05-only outcomes were first rerun on 5 September 2026 and were seen before a technical amendment permitting automatic propensity-score rematching for each outcome batch and unavoidable comparative calculations accompanying descriptive patient counts. The approved eligibility, exposure and outcome windows, codes, covariates, category boundaries and eight-test multiplicity family were not changed by that technical amendment. Subsequent technical refreshes and their source versions are recorded separately. Neither the original registration nor this amendment is presented as prospective registration of the original analysis.

Conditions

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

Keywords

Dexmedetomidine; Cardiac Surgery; Propensity Score Matching; TriNetX; Coronary Artery Bypass Grafting; Code-Defined Delirium; Electronic Health Records

Outcome Measures

Primary Outcomes (1)

• First recorded code-defined delirium or disorientation during days 1-30 after the index procedure

  Time to the first qualifying ICD-10-CM R41.0 or F05 record within the window. R41.0 includes disorientation; this is a code-defined outcome without bedside delirium assessment or individual adjudication. The CABG-coded population is primary and the valve-coded population exploratory. Patients with either code on or before day 0 in all available history are excluded before matching. The outcome-level prior-window exclusion is OFF. Analysis uses the two-sided log-rank test, Kaplan-Meier window-end failure estimates and complementary hazard ratios, subject to the documented censoring and proportionality limitations. The day-1 start is not a verified survival landmark.

  Day 1 through Day 30 after the index procedure

Secondary Outcomes (9)

• All-cause mortality during days 0-30 after the index procedure

  Day 0 through Day 30 after the index procedure

• Code-defined acute kidney injury during days 0-30

  Day 0 through Day 30 after the index procedure

• Code-defined pneumonia during days 0-30

  Day 0 through Day 30 after the index procedure

• Code-defined sepsis during days 0-30

  Day 0 through Day 30 after the index procedure

• Blood transfusion, haemorrhage-related diagnosis or thoracic exploration code during days 0-30

  Day 0 through Day 30 after the index procedure

Other Outcomes (2)

• Proportion of patients with a recorded inpatient or observation encounter during days 1-30

  Day 1 through Day 30 after the index procedure

• F05-only recorded delirium during days 1-30: sensitivity analysis

  Day 1 through Day 30 after the index procedure

Study Arms (2)

Dexmedetomidine medication record present

Eligible patients with a qualifying CABG-coded procedure and any RxNorm 48937 dexmedetomidine medication record on the preceding calendar day or the procedure day (days -1 through 0). The same medication-record definition is used in the separately constructed exploratory valve-coded population relative to its own qualifying procedure. Exposure is observed in routine records and is not assigned by investigators. Administration, dose and intraday timing are not confirmed. The CABG-coded and valve-coded populations may overlap and are reported separately.

Drug: Dexmedetomidine

Dexmedetomidine medication record absent

The corresponding eligible CABG-coded or separately constructed valve-coded population with no RxNorm 48937 dexmedetomidine medication record during days -1 through 0 relative to its qualifying index procedure. Dexmedetomidine records outside this window, including later postoperative use, are permitted. Absence of a record does not establish non-administration or identify an alternative sedative regimen. The two procedure populations have separate eligibility and matching and may contain overlapping patients.

Other: No dexmedetomidine medication record in the specified window

Interventions

Dexmedetomidine DRUG

An observed dexmedetomidine medication record (RxNorm 48937) on the calendar day before or the day of the index procedure. No drug, dose, route or regimen is assigned by the study. This entry describes the record used for exposure classification, not a study intervention.

Also known as: Precedex

Dexmedetomidine medication record present

No dexmedetomidine medication record in the specified window OTHER

Absence of a dexmedetomidine medication record during days -1 through 0 relative to the index procedure. Other care is not assigned or standardised by the investigators. Dexmedetomidine records outside the specified window are allowed.

Dexmedetomidine medication record absent

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

Patients in the TriNetX Global Collaborative Network meeting the full CABG or valve eligibility criteria during 1 January 2010 through 1 July 2025 form the study population before propensity-score matching. CABG is primary and valve exploratory, with separate procedure anchors and matching. Age at Event is 18-100 years, subject to platform privacy restrictions, with the same five-domain HCO filter. The 9 September 2026 counts were 235,752 CABG, 139,542 valve and 32,182 meeting both complete definitions. Enrollment is the overlap-adjusted platform total: 235,752 + 139,542 - 32,182 = 343,112. This is a derived count from sequential LIVE queries, not a certified fixed-time snapshot or independently verified cross-HCO person deduplication. Matched and endpoint denominators are reported separately; effects are not pooled.

You may qualify if:

• A qualifying CABG-coded procedure for the primary analysis, or a qualifying valve-coded procedure for the separate exploratory analysis, during 1 January 2010 through 1 July 2025.
• Age at Event 18-100 at a qualifying procedure, subject to the platform's additional age-related privacy restrictions.
• A procedure-date index defined by the first qualifying procedure within the clinical period after the date and age filters, with the same eligibility logic in both exposure groups within each procedure population.
• Data contributed by healthcare organisations providing demographics, diagnoses, procedures, medications and laboratory domains.
• Medication-record status classified using RxNorm 48937 during days -1 through 0 relative to the qualifying index procedure.

You may not qualify if:

• An ESRD or dialysis record during days -90 through -1: ICD-10-CM N18.6, Z49 or Z99.2; SNOMED CT 265764009; ICD-10-PCS 5A1D60Z or 5A1D00Z; or ICD-9-CM 39.95.
• Any R41.0 or F05 record on or before day 0 in all available prior history relative to the index procedure, applied before matching in both the CABG-coded and valve-coded populations. Primary, secondary, F05-only and encounter endpoints retain this eligibility definition. Native matching is repeated within each outcome batch, and identical matched patients across batches are not established.
• Some eligibility records may occur after the exposure window begins on day -1, which may introduce selection or collider bias despite application before matching. The study does not require continuous preoperative observation, complete 30-day follow-up or survival to a landmark. Missing laboratory measurements do not automatically exclude a patient. The available aggregate outputs do not permit clinical adjudication of individual procedures or confirmation that surgery is first-ever or isolated.

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

Delirium; Postoperative Complications

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

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: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)