Haloperidol effect on postoperative delirium prophylaxis

Comparison of haloperidol and placebo in the prevention of delirium after heart surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20080830001127N8

Enrollment

180

Registered

2020-04-18

Start date

2020-02-20

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

Delirium. Other delirium

Interventions

Intervention 1: Intervention group: In this group, haloperidol (HALODIC, ampoule of 5 mg per 1 ml, produced by Caspian company) with a concentration of 0.5 mg / cc will be injected immediately after t

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: All adult patients between the ages of 18 and 75 years old and candidates for elective cardiac surgery

Exclusion criteria

Exclusion criteria: History of neurological diseases Allergy to haloperidol Parkinson's disease A history of stroke Emergency surgery Previous use of anti-psychotic drugs

Design outcomes

Primary

Measure	Time frame
Delirium. Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day. Method of measurement: Using the Richmond Agitation-Sedation Scale criterion.;Intensity of delirium. Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day. Method of measurement: Using CAM-ICU confusion recognition and review tools.;Blood pressure. Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day. Method of measurement: Using a mercury barometer.;Laboratory variables (sodium ). Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day of the ICU. Method of measurement: By taking blood and determining laboratory values.;Laboratory variables(potassium ). Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day of the ICU. Method of measurement: By taking blood and determining laboratory values.;?Arterial blood gas (ABG). Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day of the ICU. Method of measurement: By taking blood and determining laboratory values.	—

Measure

Time frame

Delirium. Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day. Method of measurement: Using the Richmond Agitation-Sedation Scale criterion.;Intensity of delirium. Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day. Method of measurement: Using CAM-ICU confusion recognition and review tools.;Blood pressure. Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day. Method of measurement: Using a mercury barometer.;Laboratory variables (sodium ). Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day of the ICU. Method of measurement: By taking blood and determining laboratory values.;Laboratory variables(potassium ). Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day of the ICU. Method of measurement: By taking blood and determining laboratory values.;?Arterial blood gas (ABG). Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day of the ICU. Method of measurement: By taking blood and determining laboratory values.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEissa Bilehjani

Tabriz University of Medical Sciences

bilehjanii@tbzmed.ac.ir+98 41 3337 3950

Outcome results

None listed

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