Combination of Haloperidol and Magnesium for Delirium Prevention in Critically Ill Elderly
Condition: Delirium in Old Age
MeSH terms: Delirium
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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) 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.
    

Intervention name(s): Haloperidol Injection
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Magnesium Sulphate
Intervention MeSH terms: Magnesium Sulfate; Haloperidol; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention