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Investigation of Dexmedetomidine and Haloperidol in Delirium symptoms in Intensive Care Unit patients.

Comparison of the efficacy and adverse effects of dexmedetomidine and haloperidol in reducing the symptoms of Deliriumin patients in Intensive Care Unit - A Randomized Clinical Trial.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221128056654N1
Enrollment
74
Registered
2023-04-16
Start date
2022-12-22
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delirium. Delirium due to known physiological condition

Interventions

Intervention 1: In the group receiving dexmedetomidine manufactured by Exir pharmaceutical company, the drug is administered intravenously with a starting dose of 0.5 µg/kg per hour. To achieve the ef

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who are diagnosed with delirium based on DSM5 criteria. Patients who have not received non-pharmacological treatments to control symptoms. 5=ICDSC ? RASS=+1 Not being intubated or extubated for more than 24 hours Hospitalization in ICU for non-surgical reasons

Exclusion criteria

Exclusion criteria: Patients who receive drugs other than dexmedetomidine or haloperidol for the treatment of delirium (such as other antipsychotics and midazolam) Receiving dexmedetomidine or haloperidol within 72 hours before entering the study Patients with a history of drug sensitivity to dexmedetomidine or haloperidol. Patients with a history of long QTc (<500 ms) Patients with dementia, Parkinson's, malignant neuroleptic syndrome, patients with a history of major psychiatric disorders such as bipolar and schizophrenia, addiction to various drugs and stimulants. Women during breastfeeding and pregnancy Unwillingness of the patient or family to participate in the study Severe forms of vision and hearing

Design outcomes

Primary

MeasureTime frame
Mean score of ICDSC questionnaire. Timepoint: Intensive care Delirium Screening checklist (ICDSC) will be evaluated for daily delirium evaluation for up to 3 days. Method of measurement: Intensive care Delirium Screening checklist (ICDSC).;Mean SCORE OF RASS QUESTIONNAIRE. Timepoint: After the intervention, every hour to 6 hours, then every 1 hour to 3 days. Method of measurement: Richmond Agitation Sedation Scale (RASS).

Secondary

MeasureTime frame
ICDSC and RASS questionnaires for patients at specified intervals and results were obtained. Timepoint: Every one hour to six hours after starting the medicine and then continue every six hours to seventy two hours. Method of measurement: Richmond Agitation Sedation Scale (RASS) scoring system and also Intensive care Delirium Screening checklist (ICDSC).;Delirium intensity. Timepoint: From the time of intervention (drug prescription) daily for 3 days. Method of measurement: Patient's clinical status.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmadReza Aghabozorgi

Esfahan University of Medical Sciences

aghabozorgi.ahmadreza@gmail.com+98 31 3668 0048

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026