PROfylactic Haloperidol in Patients Defined as High Risk for DElirium With Delirium Risk mOdel

• Status: Unknown status
• Trial end date: 2018-11-23
• Target enrollment: 0
• Participant gender: All

Summary

The hospital pharmacy at the Zuyderland Medical Centre developed the DElirium MOdel (DEMO) to predict which patients are at risk of developing a delirium in patients aged 60 or older. With this delirium risk prediction model we aim to predict more accurately which patients are at high risk of developing a delirium and want to investigate if these patients can benefit from prophylactic haloperidol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zuyderland Medisch Centrum
• Treatments: Haloperidol; Haloperidol decanoate

Criteria

Inclusion criteria

• Age >60 years

• Planned elective surgery

• General surgery or orthopaedic surgery

• At least one night postsurgical admission

• High-risk developing delirium according to the DEMO-model

• Absence of delirium pre-operatively

Exclusion criteria

• Less than 1-day postoperative admission in hospital

• Hypersensitivity to butyrophenone derivates

• Use of antipsychotics

• Not being able to take oral medication

• Presence of contraindications (lesions of basal ganglia, clinical significant heart disease (eg. recent acute myocardial infarction, non-compensated heart failure, arrythmias treated with drugs out of the NYHA(New York Heart Association)-class Ia and II anti-arrythmics), known prolongation of the QT interval, history of ventricular arrythmia and torsades de pointes, uncorrected hypokalemia.