Delirium in Old AgePhase 2/3NCT06168773
Combination of Haloperidol and Magnesium for Delirium Prevention in Critically Ill Elderly
A Phase 2/3 study testing Haloperidol Injection in people with Delirium in Old Age, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- Haloperidol Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 4 Nov 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Haloperidol and Magnesium for Delirium Prevention in Critically Ill Elderly Patients After Elective Major Surgery
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.
Read the 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.
- Conditions
- Delirium in Old Age
- Being tested
- Haloperidol Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haloperidol InjectionDrug
Also called Magnesium Sulphate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Haloperidol Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for 3 days postoperatively starting the first dose 2- 4 hours after surgery.
Secondary outcomes (1)
The occurrence of extra-pyramidal symptoms.
The occurrence of extra-pyramidal symptoms, such as dystonia, tremor, myoclonus, tics, rigidity, and akathisia.
Measured: during 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Nov 2022
- Primary completion24 Oct 2023
- Study completion4 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Salah Eldin Mahmoud Badre, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168773
- Sponsor's protocol ID
- FMASU R168/2021
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: share the protocol
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Haloperidol and Magnesium for Delirium Prevention in Critically Ill Elderly Patients After Elective Major Surgery
- ClinicalTrials.gov ID
- NCT06168773
- Acronym / sponsor ID
- FMASU R168/2021
- Conditions
- Delirium in Old Age
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group I (number of patients = 45): | Experimental | Drug: Haloperidol Injectionwill 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): | Experimental | Drug: Haloperidol Injectionwill 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) | Placebo comparator | Drug: Haloperidol Injectionwill 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haloperidol InjectionAlso: Magnesium Sulphateto 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. | Drug | Group I (number of patients = 45):, Group II (number of patients= 45):, Group III (number of patients = 45) |
Primary outcome
the incidence of delirium
Time frame: for 3 days postoperatively starting the first dose 2- 4 hours after surgery.
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.
1 secondary outcome
The occurrence of extra-pyramidal symptoms.
Time frame: during 3 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: Undecided. share the protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Haloperidol Injection in people with Delirium in Old Age, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of delirium (time frame: for 3 days postoperatively starting the first dose 2- 4 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.