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

Phase 1

Recruiting

• Conditions: delirium.; Delirium due to known physiological condition

• Registration Number: IRCT20221128056654N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 74

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.