Comparison of the effect of dexmedetomidine vs midazolam infusion on the agitation level and hemodynamic changes in patients with hypertension-caused ICH and IVH

Comparison of the effect of dexmedetomidine vs midazolam infusion on the agitation level and hemodynamic changes in patients with non-traumatic ICH and IVH caused by hypertension in patients admitted to the ICU

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230101057010N1

Enrollment

Registered

2023-12-20

Start date

2023-12-22

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Nontraumatic intracranial hemorrhage. Nontraumatic intracranial hemorrhage, unspecified

Interventions

Intervention 1: Intervention group: Dexmedetomidine: This drug is a selective alpha-2-adrenoceptor agonist that can calm patients hospitalized in ICU and is available in 100MCG/2ML vials. Patients in

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: ICH or IVH due to high blood pressure ICU admission Patient intubation be at least 18 years old Consent of the patient or legal guardian in terms of entering the study

Exclusion criteria

Exclusion criteria: A heart rate of less than 60 is excluded from the study after receiving atropine. If the patient is not sedated with the maximum dose of midazolam and dexmedetomidine (Ramsay Sedation Scale above 4), the patient will be prescribed narcotics and will be excluded from the study. MAP less than or equal to 7 Lack of consent of the patient or legal guardian

Design outcomes

Primary

Measure	Time frame
Agitation level. Timepoint: It will be measured and recorded at different times, including upon arrival, the first 30 minutes after entering the ICU, and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours, and 24 hours after entering the ICU. Method of measurement: Ramsay Sedation Scale.	—

Secondary

Measure	Time frame
Vital sign. Timepoint: Upon arrival, the first 30 minutes after entering the ICU and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours and 24 hours after entering the ICU will be assessed and recorded. Method of measurement: Blood pressure measuring device, pulse oximeter, thermometer.;The need to use narcotic drugs to maintain sedation. Timepoint: Upon arrival, the first 30 minutes after entering the ICU and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours and 24 hours after entering the ICU will be assessed and recorded. Method of measurement: Ramsay Sedation Scale.	—

Measure

Time frame

Vital sign. Timepoint: Upon arrival, the first 30 minutes after entering the ICU and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours and 24 hours after entering the ICU will be assessed and recorded. Method of measurement: Blood pressure measuring device, pulse oximeter, thermometer.;The need to use narcotic drugs to maintain sedation. Timepoint: Upon arrival, the first 30 minutes after entering the ICU and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours and 24 hours after entering the ICU will be assessed and recorded. Method of measurement: Ramsay Sedation Scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMisagh Rostami

Karaj University of Medical Sciences

misagh.rostami1988@gmail.com+98 26 3442 7001

Outcome results

None listed

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