Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Delirium

Treatments: Drug: Fentanyl; Drug: Dexmedetomidine; Drug: midazolam

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02080169

CMAqiluICU

Details and patient eligibility

About

It is well known that ICU patients need sedation. Now no ideal sedation drug existed and every sedation drug has its advantage and disadvantage,so combined sedation may use the advantage and avoid the disadvantage of the sedation drug according to the patients'condition. Until now, there is rare study about the combined sedation or sequenced sedation of different sedation drug.The purpose of the study is to explore the value of combined sedation with midazolam and dexmedetomidine compared to single drug sedation in ICU, so as to seek an ideal sedation protocol that could reduce the cost of treatment,obtain the appropriate sedation not under sedation or over sedation,reduce the incidence of delirium, reduce the adverse event of sedation.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ICU patients needing sedation
2. 18 years or older
3. mechanically ventilated for less than 96 hours prior to start of study drug.

Exclusion criteria

1. Trauma and burn patients as admitting diagnosis.
2. Dialysis of all types.
3. Pregnant or lactation.
4. Neuromuscular blockade other than for intubation.
5. Epidural or spinal analgesia.
6. General anesthesia prior to or planned after the start of study drug infusion
7. Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia).
8. Acute hepatitis or severe liver disease (Child-Pugh class C).
9. Unstable angina or acute myocardial infarction.
10. Left ventricular ejection fraction less than 30%,heart rate less than 50/min. 11.Second or third degree heart block.

12.Allergy to the study drug. 13.Systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.

14. Patients with renal insufficiency were randomized and treated; however, patients were discontinued if they required dialysis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

midazolam

Experimental group

Description:

Initiative dosage of midazolam is 0.05 mg/kg given intravenously, the maintenance dosage is 0.01-0.05 mg/kg/h, drug dosage is adjusted by target sedation level.

Treatment:

Drug: Fentanyl

Drug: midazolam

Dexmedetomidine

Experimental group

Description:

The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min, the maintenance dosage is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.

Treatment:

Drug: Fentanyl

Drug: Dexmedetomidine

midazolam & dexmedetomidine

Experimental group

Description:

Initiative dosage of midazolam is 0.05 mg/kg given intravenously, The loading dose of dexmedetomidine is 0.5-0.8 μg/kg given intravenously more than 10 min(given or not according to patients' condition),. The maintenance dosage of midazolam is 0.01-0.05 mg/kg/h, the maintenance dosage of dexmedetomidine is 0.2-0.7 μg/kg/h,the drug dosage is adjusted by target sedation level.

Treatment:

Drug: Fentanyl

Drug: midazolam

Drug: Dexmedetomidine