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Effect of Sedation With Dexmedetomidine-esketamine Combination on Delirium in Postoperative ICU Patients: a Randomized Controlled Pilot Trial

Effect of Sedation With Dexmedetomidine-esketamine Combination on Delirium in Postoperative ICU Patients: a Randomized Controlled Pilot Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110737
Enrollment
Unknown
Registered
2025-10-20
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Postoperative delirium

Interventions

Dexmedetomidine group:The formula is dexmedetomidine 200µg/2ml, diluted to 50ml with normal saline (dexmedetomidine concentration is 4µg/ml).
Dexmedetomidine-esketamine group:The formula consists of 100µg/1ml of dexmedetomidine and 50mg/2ml of esketamine, diluted to 50ml with normal saline (dexmedetomidine concentration is 2µg/ml, esketamin

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged 60 years or older; 2.Admitted to the intensive care unit (ICU) after surgery; 3.Expected to stay in the ICU for at least one night.

Exclusion criteria

Exclusion criteria: 1.History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis; 2.Presence of preoperative delirium, or inability to communicate due to coma, severe dementia, or language barrier; 3.Previously diagnosed obstructive sleep apnea, judged to be at high risk of moderate-to-severe obstructive sleep apnea according to the STOP-Bang questionnaire, or have a body mass index >30 kg/m^2; 4.Preoperative left ventricular ejection fraction <30%, sick sinus syndrome, severe sinus bradycardia (heart rate <50 bpm), second-degree or higher atrioventricular block without a pacemaker, or systolic blood pressure <90 mmHg despite use of vasopressors; 5.Comorbid with hyperthyroidism or pheochromocytoma; 6.Severe liver dysfunction (Child-Pugh Class C), severe renal dysfunction (requiring dialysis), or expected survival <=24 hours; 7.After traumatic brain injury or neurosurgery; 8.Allergy to dexmedetomidine and/or esketamine; 9.Other conditions that are considered unsuitable for study participation;

Design outcomes

Primary

MeasureTime frame
Incidence of delirium within 7 days;Incidence of cognitive dysfunction at 30 days;

Secondary

MeasureTime frame
Plasma concentrations of Aß42, p-tau217, p-tau181, S100B, GFAP, IL-1ß, IL-6, IL-10, and TNF-a measured at 08:00 on postoperative day 1.;Postoperative pain score within 7 days;Length of stay in hospital after surgery;Length of stay in the ICU;Incidence of major complications within 30 days;Postoperative subjective sleep quality within 7 days;Total sleep time (TST) on the first postoperative night;

Countries

China

Contacts

Public ContactDong-Xin Wang

Peking University First Hospital

wangdongxin@hotmail.com+86 10 83572784

Outcome results

None listed

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