Clinical trial NCT02080169: Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients
Official title: Safety and Efficacy of Combined Sedation With Midazolam and Dexmedetomidine in ICU Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Delirium
Keywords: Intensive care unit
Mechanical ventilation
Combined sedation
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Chinese Medical Association
First posted: 2014-03-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: The total time within target sedation level
timeFrame: From sedation drug is used to weaning from sedation up to 28 days.
Secondary outcomes:
measure: The dosage of sedation/analgesic drug
timeFrame: From sedation/analgesic drug is used to weaning from sedation/analgesic up to 28 days.
measure: Duration of mechanical ventilation
timeFrame: From beginning to weaning from ventilation up to 28 days..
measure: Economic outcome
timeFrame: From admitted to ICU until ventilation and sedation stopped and participants discharged from ICU up to 28 days.
measure: Satisfactory of patients to ICU stay from admitted until discharged from ICU
timeFrame: Assessed at time of 1 week participants discharged from ICU.
measure: Delirium
timeFrame: From sedation drug is used to weaning from sedation, up to 28 days.
measure: Vital signs
timeFrame: From sedation drug is used to weaning from sedation, up to 28 days.
measure: Duration of ICU stay
timeFrame: From date of admission until participants discharged from ICU up to 28 days.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department ICU, Shandong university affiliated Qilu Hospital.
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Da W Wu, Doctor.
role: STUDY_DIRECTOR
References: