Sequential Use of Propofol/Midazolam and Dexmedetomidine for Sedation in Mechenical Ventialtion Patients in ICU.

Tianjin Third Central Hospital

Status and phase: Unknown; Phase 4

Conditions: Mechanical Ventilation Complication

Treatments: Drug: Fentanyl; Procedure: Screen of weaning; Procedure: Sedation assessment; Drug: Propofol; Drug: Dexmedetomidine; Drug: Midazolam

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02122055

CMATJHICU

Details and patient eligibility

About

For the patient who passed the screen of weaning from ventilation, the traditional sedation drug such as propofol and midazolam should be decreased or stopped, then it would induce the stress response and agitation, such as hypertension,tachycardia etc. In order to resolve that problem, the sedation should be given again. but if renewed to sedation, it would cause prolonged sedation and ventilation duration.

So as to resolve above issues, after the patient passed the screen of weaning, sedation is changed to Dexmedetomidine, a new sedation drug, that could wake up at any time. So our study to compare the efficacy and safety of sequential sedation of propofol or midazolam and dexmedetomidine in mechanical ventilated ICU patients.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written Informed Consent
2. Anticipated Ventilation and sedation duration of at least 48 hours
3. Age≥18 years old
4. Weight is in the range of ±20% of standard weight.[Standard weight= (Height(cm)-80)×70﹪ for male and (Height(cm)-70)×60﹪for female] -

Exclusion criteria

1. Extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm Hg despite continuous infusions of vasopressors before the start of study drug infusion or shock；
2. Heart rate less than 50 bpm
3. Second or third degree heart block
4. Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia)
5. Acute hepatitis or severe liver disease (Child-Pugh class C)
6. Dialysis of all types 7）History of neuromuscular disease

8. Unstable mental status and metal illness 9) Sure or suspected abuse of narcotics and alcohol independence 10) Allergy to experimental drug and other contraindication 11) Advanced tumor patients 12) Neuromuscular blockade other than for intubation 13) Pregnancy or lactation 14) Patient that participate other trial at past 30 days -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Propofol/Dexmedetomidine

Experimental group

Description:

1. Propofol is started with dosage of 0.3 mg/kg/h, observe the patient's response, increase 0.3 mg/kg/h propofol every 10 minutes until target sedation level is obtained(Riker Sedation Agitation Score(SAS) 3-4),then 0.3-3 mg/kg/h propofol is maintained. 2. After the screen of the weaning is passed, change to Dexmedetomidine sedation, the dose is 0.2-0.7 mg/kg/h and continuously pumped, increase the dose 0.1-0.2 mg/kg/h every 30 minutes, titrate to Riker Sedation Agitation Score(SAS) 3-4，the maximum dose is 1 mg/kg/h maintained，and prepare for weaning.

Treatment:

Procedure: Sedation assessment

Drug: Fentanyl

Drug: Dexmedetomidine

Procedure: Screen of weaning

Drug: Propofol

Midazolam/Dexmedetomidine

Experimental group

Description:

1. Midazolam 2 mg is slowly titrated to Riker Sedation Agitation Score(SAS) 3-4 every 10 minutes, then Midazolam 0.02-0.1 mg/kg/h is maintained. 2. After the screen of the weaning is passed, change to Dexmedetomidine sedation, the dose is 0.2-0.7 mg/kg/h and continuously pumped, increase the dose 0.1-0.2 mg/kg/h every 30 minutes, titrate to Riker Sedation Agitation Score(SAS) 3-4，the maximum dose is 1 mg/kg/h maintained，and prepare for weaning.

Treatment:

Procedure: Sedation assessment

Drug: Midazolam

Drug: Fentanyl

Drug: Dexmedetomidine

Procedure: Screen of weaning