Prospective, randomized,double-blind, parallel controlled clinical study on the efficacy and safety of olanzapine and dexmedetomidine in the treatment of ICU delirium

Efficacy and safety of olanzapine and dexmedetomidine in the treatment of ICU delirium

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100049820

Enrollment

Unknown

Registered

2021-08-10

Start date

2021-09-22

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Delirium

Interventions

Experimental group1:Olanzapine is administered orally or via a nasogastric tube. The initial dose is 5 mg/day, and the control of delirium (including the presence of violence, tendency to extubate, or

Experimental group2:The administration route of dexmedetomidine is continuous intravenous infusion. The initial dose is 0.1 mcg/kg/h. The RASS sedation score is assessed every 15 minutes, and the infu

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 or above who have been admitted to the ICU for more than 24 hours; 2. Meet the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria; 3. Sign the informed consent form containing the phone number of the patient or family member when admitted to the ICU.

Exclusion criteria

Exclusion criteria: 1. History of neurological diseases such as stroke, dementia, brain tumor or traumatic brain injury; 2. Contraindications or allergies to olanzapine and dexmedetomidine; 3. Advanced tumor; 4. Pregnancy and breastfeeding; 5. Patients with a history of alcohol or drug abuse; 6. History of torsades de pointes ventricular tachycardia; 7. QT interval prolongation (QT>440 ms); 8. Receive blood purification treatment during the use of olanzapine or dexmedetomidine (may affect the pharmacokinetics and efficacy of olanzapine or dexmedetomidine); 9. Routinely taking any benzodiazepines or any antipsychotics; 10. The efficacy and adverse reactions cannot be evaluated due to incomplete data and inconsistent evaluation criteria; 11. Concurrent participation in another study or trial.

Design outcomes

Primary

Measure	Time frame
Survival days without delirium or coma;	—

Secondary

Measure	Time frame
Delirium duration;Endotracheal intubation rate during medication;Intensive Care Unit length of stay;Delirium recurrence rate;Survival time of 30 and 90 days;Cognitive outcome;	—

Countries

China

Contacts

Public ContactLiu Sibo

Dalian Municipal Central Hospital

icu2000@163.com+86 411 8441 2001

Outcome results

None listed

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