DExmedetomidine in Cardiac surgical Intraoperative Drug Evaluation

Dexmedetomidine in Cardiac surgical intraoperative drug evaluation (DECIDE): a triple-blind, placebo-controlled, randomised trial evaluating whether dexmedetomidine improves: cognition, days alive and coma free in patients aged 65 years or older.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623001171606

Acronym

DECIDE

Enrollment

166

Registered

2023-11-13

Start date

2024-11-13

Completion date

2027-08-30

Last updated

2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Delirium (confusion) is a common complication of cardiac surgery. Dexmedetomidine, a routinely used sedative, has been shown to reduce delirium in different populations. This study aims to test if dexmedetomidine can reduce delirium after surgery in patients undergoing cardiac surgery aged 65 years or older. The aim of the study is to see whether a medication called dexmedetomidine (a routinely used sedative) impacts delirium after surgery. We hypothesize that dexmedetomidine will reduce delirium after surgery.

Interventions

Dexmedetomidine, 0.7 mcg/kg/h intraoperatively and 0.1-1 mcg/kg/h until extubation, administered intravenously.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adults undergoing cardiac surgery with cardiopulmonary bypass 2. Age 65 years and older 3. Sufficient English language to complete the cognitive testing in the opinion of the research team 4. Willing and able to comply with all study requirements, including treatment, timing, and assessments.

Exclusion criteria

1. Dementia (pre-existing confirmed clinical diagnosis) 2. Known allergy to Dexmedetomidine (DEX) 3. Second or third-degree heart block 4. Heart rate less than 55 unless on concomitant beta blockade 5. Renal dialysis within 30 days of surgery 6. Life expectancy of less than 30 days regardless of surgery 7. Preoperative mechanical support other than intra-aortic balloon pump 8. Salvage surgery requiring cardiopulmonary resuscitation 9. Child-Pugh class C liver Cirrhosis 10. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the study procedures. 11. Hearing loss, or medical or psychiatric condition that could preclude the ability of the patient to comply with study procedures. 12. Prior enrolment in DECIDE trial in prior 12 months.

Outcome results