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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Hospital; Qilu Hospital of Shandong University
• Collaborator: Chinese Medical Association
• Treatments: Dexmedetomidine; Fentanyl; Midazolam

Criteria

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.