Status:
COMPLETED
Combination of Haloperidol and Magnesium for Delirium Prevention in Critically Ill Elderly
Lead Sponsor:
Ain Shams University
Conditions:
Delirium in Old Age
Eligibility:
All Genders
65-80 years
Phase:
PHASE2
PHASE3
Brief 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 ris...
Detailed Description
This prospective randomized double-blind placebo-controlled study will be conducted in Ain Shams university surgical ICU on 135 patients aged ≥ 65\< 80 years old with PRE-DELIRIC Score 50% or more (20...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2023
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06168773
Start Date
November 1 2022
End Date
November 4 2023
Last Update
December 13 2023
Active Locations (1)
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1
AinShams university hospitals
Cairo, Egypt