Combination of Haloperidol and Magnesium for Delirium Prevention in Critically Ill Elderly

• Status: Completed
• Trial end date: 2023-11-04
• Target enrollment: 0
• Participant gender: All

Summary

Objective: The aim of this randomized double blinded study is to investigate the effectiveness and safety of the prophylactic use of haloperidol with or without magnesium (Mg) for delirium in high risk elderly patients postoperatively.

Patients and methods: 135 patients aged ≥ 65< 80 years old with PRE-DELIRIC Score 50% or more (20) were admitted to the ICU non-intubated following major non cardiac surgeries randomized into 3 groups, Group I received 1 mg haloperidol intravenously 3 times daily and magnesium sulfate 4 g intravenous infusion (IVI) in 1st day (diluted in 50 ml D5W over 24 hours) then 2g IVI over 24 hours (diluted in 50 ml D5W over 24 hours) for 3 days, Group II received 1 mg haloperidol intravenously 3 times ,Group III received 1 mL 0.9% of sodium chloride intravenously 3 times daily. The primary outcome of the study will be the incidence of delirium.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Haloperidol; Haloperidol decanoate; Magnesium Sulfate

Criteria

Inclusion Criteria:

• PRE-DELIRIC Score 50% or more (20) who are admitted to the ICU non-intubated following major non cardiac surgeries and anticipated intensive care unit (ICU) stay of at least 2 days as estimated by the attending intensivist

Exclusion Criteria:

• sustained RASS of -4/-5 during the complete ICU admission

• primary neurologic event/injury with GCS ≤ 9 during the first 48 hours of ICU

• delirium prior to inclusion, Parkinson disease, dementia, alcohol abuse, an acute neurological condition, history of a psychiatric disease and use of antipsychotic agents

• history of clinically relevant ventricular arrhythmia in the last 12 months, QTc time of at least 500 milliseconds

• recent MI or cardiac decompensation, 2nd or 3rd AV block

• Known allergy or intolerance to haloperidol or magnesium sulphate.

• 80 years or older, had a body weight of 50 kg or less, or had liver failure (serum bilirubin level >2.9 mg/dL) or serum creatinine level >150 μmol/L

• Intubated patients at the time of ICU admission.