The effect of Subanaesthetic Esketamine in the prevention of Delirium in Elderly patients after Cardiac surgery: a single center, randomized controlled, double-¬blinded, placebo-controlled trial (SEDCE trial)

The effect of Subanaesthetic Esketamine in the prevention of Delirium in Elderly patients after Cardiac surgery: a single center, randomized controlled, double-blinded, placebo-controlled trial (SEDCE trial)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300074395

Enrollment

Unknown

Registered

2023-08-04

Start date

2023-09-01

Completion date

Unknown

Last updated

2024-11-04

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

Conditions

postoperative delirium

Interventions

Placebo control group:0.9% saline

Experimental group:Esketamine

Eligibility

Sex/Gender

All

Age

60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients selected to undergo open heart surgery; 2. Aged from 60 to 80 years old; 3. The surgery category including coronary artery bypass grafting (off/on-pump), heart valve surgery or coronary artery bypass grafting combined with heart valve surgery and patients with type A Aortic dissection; 4. General anesthesia time >= 4 hours, postoperative hospitalization time >= 5 days; 5. Patients agree to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with Contraindication or allergic to esketamine and other narcotic drugs; 2. Patients with preoperative grade III hypertension, tachycardia, and poor drug control; 3. MMSE scores (illiteracy<17, primary school education < 20, education level at high school or above < 24), preoperative brain edema, severe intracranial hypertension, glaucoma, hyperthyroidism patients, coma patients; 4. Previously diagnosed with dementia, mental illness, or taking antidepressants; 5. Severe impairment of auditory, visual, and language system functions; 6. Unable to understand Mandarin or Henan dialect; 7. Alcoholics or drug addicts; 8. Patients with poor general condition, combined with a history of multiple serious systemic diseases, and an expected life expectancy of less than 3 months; 9. History of heart failure, preoperative EF = 40%; 10. Patients with a history of cerebral infarction, cerebral haemorrhage, and central nervous system sequelae; 11. Patients with cerebral vascular stenosis (vertebral artery/internal carotid artery, one or both sides) = 70%; 12. Confirm or suspect the use of narcotic sedative Analgesic; 13. Participating in another current research.

Design outcomes

Primary

Measure	Time frame
postoperative delirium;	—

Secondary

Measure	Time frame
Sleep Quality;duration of postoperative mechanical ventilation, length of hospital and ICU stay;	—

Countries

China

Contacts

Public ContactHongqi Lin

Fuwai Central China Cardiovascular Hospital

lhq9988@126.com+86 156 1777 0159

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026