drugset / Trial / NCT06168773

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

NCT06168773

Phase 2/3 Completed 135 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2022-11-01
Primary completion
2023-10-24
Completion
2023-11-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Haloperidol Other / unclassified 1 mg Intravenous
Subject Magnesium Sulfate Other / unclassified 2 g Intravenous

Indications