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comparison of dexmedetomidine and propofol sedation in ICU

Comparison of dexmedetomidine and propofol for sedation in patients requiring mechanical ventilation in ICU: A randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230828059291N1
Enrollment
70
Registered
2023-09-09
Start date
2023-09-14
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Sedation in ICU patients.

Interventions

Intervention 1: Intervention group 1: Group A will receive ?Dexmedetomidine with a loading dose of 1 µg/kg for 10 minutes followed by a maintenance infusion of 5 µg/kg/hr (0.2-0.7 µg/kg/hr). If the ta
A propofol bolus of 0.2 mg/kg will be injected for a maximum of three consecutive boluses at an interval of 3 to 5 minutes. Intervention 2: Intervention group 2: Group B will receive Propofol with an
A propofol bolus of 0.2 mg/kg will be injected for a maximum of three consecutive boluses at an interval of 3 to 5 minutes.

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients over 18 years old staying in ICU for at least 24 hours after surgery need to be intubated and be sedated

Exclusion criteria

Exclusion criteria: Hypotension (SBP<90) pregnant women obesity (body weight more than 50% higher than ideal body weight) ESRD patients Glasgow Coma Scale (GCS) below 12 (moderate and severe brain damage) Significant arrhythmia or high degree of atrioventricular node block patients who are allergic to the drugs

Design outcomes

Primary

MeasureTime frame
Comparison of the need for narcotic drug (fentanyl) in dexmedetomidine and propofol groups. Timepoint: The amount of injected fentanyl will be measured at the end of 24 hours. Method of measurement: The amount of fentanyl injection will be recorded during the study.

Secondary

MeasureTime frame
Respiratory parameters (respiratory rate, spontaneous breathing and airway pressure). Timepoint: Respiratory parameters will be recorded at intervals of 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours and 24 hours. Method of measurement: The mentioned variables are measured by ventilator devices and then recorded at the time intervals.;Level of consciousness. Timepoint: The level of consciousness will be recorded at intervals of 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours and 24 hours. Method of measurement: The level of consciousness will be measured by Ramsay Sedation Scale.;Hemodynamic parameters (systolic and diastolic blood pressure, heart rate, mean arterial blood pressure). Timepoint: Hemodynamic parameters will be recorded at intervals of 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours and 24 hours. Method of measurement: The monitoring device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Hossein Saadati

Babol University of Medical Sciences

Asaadati1997@gmail.com+98 911 754 2722

Outcome results

None listed

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