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

Delirium in Old Age Clinical Trial

Official title:

Combination of Haloperidol and Magnesium for Delirium Prevention in Critically Ill Elderly Patients After Elective Major Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06168773
• Other study ID #: FMASU R168/2021
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 1, 2022
• Est. completion date: November 4, 2023

Study information

• Verified date: December 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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) 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 after the approval of the research ethical committee and obtaining patients' or patients ' relatives written informed consent.

The study medications are continued until ICU discharge or until delirium occurred. In the latter case, study medications are stopped, and patients could be treated with dexmedetomidine.

For delirium prevention non-pharmacological interventions are also implemented like early mobilization, improving patient circadian rhythm, noise reduction are parts of the daily ICU care.

Patients will receive fentanyl infusion for analgesia. Those patients achieving a RASS score of ± 1 or 0 are monitored daily for delirium using the Confusion Assessment Method for the ICU (CAM-ICU). Patients are diagnosed with delirium if they have at least 1 positive CAM-ICU without RASS -4/-5 during a complete day. Clinicians collecting data on delirium are all experienced in delirium assessment using the CAM-ICU. All patients are screened at least three times daily, and more often if required.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 4, 2023
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age

Intervention

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.

Locations

Country	Name	City	State
Egypt	AinShams university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of delirium	Patients will receive fentanyl infusion for analgesia. Those patients achieving a RASS score of ± 1 or 0 are monitored daily for delirium using the Confusion Assessment Method for the ICU (CAM-ICU). Patients are diagnosed with delirium if they have at least 1 positive CAM-ICU without RASS -4/-5 during a complete day.	for 3 days postoperatively starting the first dose 2- 4 hours after surgery.
Secondary	The occurrence of extra-pyramidal symptoms.	The occurrence of extra-pyramidal symptoms, such as dystonia, tremor, myoclonus, tics, rigidity, and akathisia.	during 3 days postoperative