Comparative study of the effect of haloperidol and dexmedetomidine on Restlessness in mechanically ventilated patients following concussion admitted to the intensive care unit of Imam Khomeini Hospital

Comparative study of the effect of Haloperidol and Dexmedetomidine on delirium and agitation in mechanically ventilated patients following concussion admitted to the intensive care unit

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200803048288N1

Enrollment

Registered

2020-09-01

Start date

2019-04-22

Completion date

Unknown

Last updated

2020-09-07

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: Intervention group 1: In addition to routine care, patients in the first group will be injected with 2.5 mg of haloperidol as a bolus and then 2.5-5 mg / h as an infusion of haloperido

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: APACHE II criteria more than 48 RASS criteria between +1 to +4 At least 48 hours after hospitalization in the intensive care unit

Exclusion criteria

Exclusion criteria: Dissatisfaction of the patient's legal guardian Patients who are candidates for surgery Unstable hemodynamic status History of mental illness or use of neuroleptics History of drug use any contraindications to Dexmedetomidine or Haloperidol (Allergy, Parkinson's, Hypotension, BradyCardiac) Renal or Hepatic Fysfunction

Design outcomes

Primary

Measure	Time frame
Delirium. Timepoint: Every 6 hours a day for 7 days. Method of measurement: APACHE II criteria.;Agitation. Timepoint: Every 6 hours a day for 7 days. Method of measurement: APACHE II criteria.	—

Secondary

Measure	Time frame
Duration of hospital stay. Timepoint: Daily. Method of measurement: Total days of hospitalization after receiving the intervention.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Darkhor

Ahvaz University of Medical Sciences

Darkhor.r@ajums.ac.ir+98 61 3373 8383

Outcome results

None listed

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