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

NCT06168773 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: FMASU R168/2021
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The occurrence of extra-pyramidal symptoms.

  during 3 days postoperative

Study Arms (3)

Group I (number of patients = 45):

EXPERIMENTAL

will receive 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 postoperatively starting the first dose 2- 4 hours after surgery. If the first prophylactic dose is delayed for more than 4 hours post admission, patient is excluded from the study.

Drug: Haloperidol Injection

Group II (number of patients= 45):

EXPERIMENTAL

will receive 1 mg haloperidol intravenously 3 times daily and 50 ml of D5W IVI infusion over 24 hours for 4 days postoperatively starting the first dose 2- 4 hours after surgery.

Drug: Haloperidol Injection

Group III (number of patients = 45)

PLACEBO COMPARATOR

will receive 1 mL 0.9% of sodium chloride intravenously 3 times daily and 50 ml of D5W IVI infusion for 4 days postoperatively starting the first dose 2- 4 hours after surgery.

Drug: Haloperidol Injection

Interventions

Haloperidol Injection DRUG

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.

Also known as: Magnesium Sulphate

Group I (number of patients = 45):; Group II (number of patients= 45):; Group III (number of patients = 45)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• sustained RASS of -4/-5 during the complete ICU admission
• primary neurologic event/injury with GCS ≤ 9 during the first 48 hours of ICU
• 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.
• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams university hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Haloperidol; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: prospective randomized double-blind placebo-controlled study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Model Details: Group I (number of patients = 45): will receive 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 postoperatively starting the first dose 2- 4 hours after surgery. If the first prophylactic dose is delayed for more than 4 hours post admission, patient is excluded from the study. Group II (number of patients= 45): will receive 1 mg haloperidol intravenously 3 times daily and 50 ml of D5W IVI infusion over 24 hours for 4 days postoperatively starting the first dose 2- 4 hours after surgery. Group III (number of patients = 45): will receive 1 mL 0.9% of sodium chloride intravenously 3 times daily and 50 ml of D5W IVI infusion for 4 days postoperatively starting the first dose 2- 4 hours after surgery.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: November 1, 2022
• Primary Completion: October 24, 2023
• Study Completion: November 4, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

EG (1)