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

NCT06168773 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2023-12-13

No results posted yet for this study

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.

Conditions

  • Delirium in Old Age

Interventions

DRUG

Haloperidol Injection

to evaluate the efficacy and safety of short-term intravenous combination of low-dose haloperidol and magnesium for delirium prevention in critically ill elderly patients after elective major surgery.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-10-24
Completion
2023-11-04
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168773 on ClinicalTrials.gov