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Efficacy and safety of zotepine in critically ill patients with agitation: A prospective, cohort observational study

Efficacy and safety of zotepine in critically ill patients with agitation: A prospective, cohort observational study - Efficacy and safety of zotepine in critically ill patients with agitation: A prospective, cohort observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037989
Enrollment
25
Registered
2019-09-20
Start date
2015-08-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Agitation in the intensive care unit

Interventions

Administration of zotepine 25-50 mg at a time, additional dose can be given 8 hours later. Administration of quetiapine 25-50 mg at a time, additional dose can be given 8 hours later.

Sponsors

Pharmaceutical Department, JA Hiroshima General Hospital and Division of Emergency and Critical Care Medicine, JA Hiroshima General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 16 years old and more 2. Enteral nutrition can be administered 3. The physician considered the use of propofol newly in Richmond Agitation-Sedation Scale + 1 and more (agitation)

Exclusion criteria

Exclusion criteria: 1. Intensive Care Delirium Screening Checklist 3 and less 2. Admitted with a primary neurologic condition or injury (e.g., intracranial hemorrhage, active seizure) 3. History of hepatic encephalopathy or end-stage liver disease 4. Actively withdrawing from alcohol 5. Treatment with an antipsychotic agent in the 30 days before ICU admission 6. Current treatment with a neuromuscular blocker 7. Current treatment with an agent having either the potential to affect quetiapine concentrations (e.g., phenytoin) 8. Increase the risk for QTc prolongation 9. Baseline QTc interval 500 sec and more 10. Pregnancy 11. Non-Japanese speaking 12. Presence of a condition preventing of assessment Intensive Care Delirium Screening Checklist 13. Prognosis considered hopeless 14. Refused by the patient or family 15. The decision of physician

Design outcomes

Primary

MeasureTime frame
Proportion of patients with Intensive Care Delirium Screening Checklist < 4 on the next observation day following first dose

Secondary

MeasureTime frame
Proportion of patients with maximum blood glucose level 180 mg/dL or more for 24 hours after taking study drug

Countries

Japan

Contacts

Public ContactShodai Yoshihiro

JA Hiroshima General Hospital Pharmaceutical Department

syoshihiro-ja@umin.ac.jp0829-36-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026