Sedation Protocols and Skeletal Muscle Metabolism in Mechanical Ventilated Patients

Chinese Medical Association

Status: Unknown

Conditions: Sedative, Hypnotic, or Anxiolytic Use Disorders; Hypercatabolism

Treatments: Drug: Midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03402113

Gulou ICU

Details and patient eligibility

About

To investigate the effects of different sedation protocols on skeletal muscle metabolism in mechanical ventilated patients in ICU. Mechanical ventilated patients who are anticipated to stay in ICU for more than 5 days are enrolled and randomly assigned to the following three groups, interventional group(dexmedetomidine), control group(midazolam) and no sedation group. Serum, CT scan of intercostal muscles, ultrasound evaluation of quadriceps femoris are obtained.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• mechanical ventilated for more than 48h
• 18-80 years
• stay in ICU for more than 5 days

Exclusion Criteria

• already participated in other clinical trials
• pregnancy or lactation
• lower limb amputation
• primary neuro-muscular disease
• disseminated tumor or accepted special therapy
• alcohol abuse
• severe liver dysfunction(Child-Push C)
• unstable angina/acute myocardial infarction
• heart rates<50bpm
• all kinds dialysis
• severe burn
• epidural anesthesia
• severe neurological disease（acute stroke, uncontrollable epilepsy, severe dementia, etc）

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Dexmedetomidine group

Experimental group

Description:

Dexmedetomidine consistent infusion as sedative.

Treatment:

Drug: Dexmedetomidine

Midazolam group

Active Comparator group

Description:

Midazolam consistent infusion as sedative.

Treatment:

Drug: Midazolam