Delirium in Acute Neurocritical Patient; Comparative Efficacy of Dexmedetomidine vs. Antipsychotics (Quetiapine and Haloperidol)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005367

Enrollment

102

Registered

2020-09-02

Start date

2020-09-03

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

None listed

Interventions

Drug : We describe herein the methodology of a prospective, randomized, and multicenter trial comparing Dexmedetomidine Group vs. Antipsychotic Group (Quetiapine, Haloperidol) in neuro ICU target for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of delirium using Korean version of CAM-ICU or by intensivists using Intensive Care Delirium Screening checklist (ICDSC) 2. Age =18 years and = 90 years 3. Glasgow Coma Score (GCS): 9-15 4. Operation or non-operation cases 5. Expected ICU stay > 48 hours

Exclusion criteria

Exclusion criteria: 6. Safety concerns with drug administration: Heart rate <50 beats/minute, known preoperative left ventricular ejection fraction less than 30%, 2° or greater AV block in the absence of a pacemaker, sick sinus syndrome, torsades de pointes, prolonged corrected QT (> 550 ms) from the baseline EKG 7. History of severe dementia, schizophrenia, Parkinsonism, or myasthenia gravis 8. Current treatment with dexmedetomidine or clonidine 9. Dexmedetomidine or antipsychotics (quetiapine or haloperidol) allergic history 10. Post-anoxic coma; status epilepticus without underlying brain injury; central nervous system (CNS) infections (community-acquired; hospital-acquired; ventriculitis; post-operative) 11. History of hepatic encephalopathy or end stage liver disease (Child- Pugh Class B or C) 12. Pregnancy or Nephrotic syndrome diagnosed patient 13. Brain death or imminent death (within 24 hours) 14. DNR (do not resuscitate) orders

Design outcomes

Primary

Measure	Time frame
Non-delirium diagnosed days after drug administration	—

Secondary

Measure	Time frame
The length of delirium period after the drug administration;The length of intensive care unit admission;The length of hospiral admission;30 day neurologic outcome assessment using modifed Rankin Scale (mRS) and Glasgow Outcome Scale (GOS)	—

Countries

Korea, Republic of

Contacts

Public ContactSeungjoo Lee

University of Ulsan

Outcome results