JPRN-jRCTs051220122RecruitingPhase 4
Preventive effect of active Protocol-Based Pharmacotherapy Management for delirium in general wards of emergency department: A Single-Center, Randomized Controlled Trial - aPBPM trial
Ohtsuru Shigeru0 sites105 target enrollmentStarted: November 25, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 105
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 65age old to ot applicable (—)
- Sex
- All
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
Investigators
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