Preventive effect of active Potocol-Based Pharmacotherapy Management for delirium

Phase 4

Recruiting

• Conditions: Delirium

• Registration Number: JPRN-jRCTs051220122
• Lead Sponsor: Ohtsuru Shigeru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1) Patients who are admitted to the general ward of the department of primary care and emergency medicine from the emergency room between 8:30 and 17:00 on weekdays.
2) One or more of the following six risk factors for developing delirium: central nervous system disease, cognitive dysfunction, history of high alcohol intake, history of delirium, use of drugs at risk of delirium, Post-surgery or scheduled surgery requiring general anesthesia.
3) Patients over 65 years old.

Exclusion Criteria

1) Patients with schizophrenia
2) Patients taking antipsychotics.
3) Patients who cannot be hospitalized for more than48 hours.
4) Patients taking benzodiazepines prescribed by a psychiatrist or psychosomatic physician
5) Patients taking CYP3A4 inhibitors (itraconazole, clarithromycin, erythromycin, fluconazole, verapamil, HIV protease inhibitor, etc.)
6) Patients taking Ramelteon or lemborexant
7) Blonanserin patch is applied
8) Patients with severe liver dysfunction
9) Patients with severe disturbance of consciousness
10) Sedatives are used before the start of the study
11) Patients with drug abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of delirium diagnosed with DSM-5 within 3 days of hospitalization

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of delirium within 3 days of hospitalization, Incidence of delirium diagnosed with DSM-5 by study drug within 3 days of hospitalization, Total score (worst value for 3 days) of DRS-R98-J (Japanese version of the delirium Rating Scale, Revised-98), Severity score (worst value for 3 days) of DRS-R98-J, Score for item 1 of DRS-R98-J, Sleep-wake cycle disturbance, Total dose of rescue drug hydroxyzine, Incidence of restlessness within 3 days of hospitalization, Incidence of restlessness and agitation associated with dementia within 3 days of hospitalization