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

NCT02122055 | Unknown Phase 4

• 1 other identifier: CMATJHICU
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mechanical Ventilation Complication

Keywords

combined sedation

Outcome Measures

Primary Outcomes (1)

• Ventilation duration

  The time of intubation and the time of weaning from mechanical ventilation are recorded.

  From intubation to weaning from mechanical ventilation, up to 7 days.

Secondary Outcomes (8)

• Delirium

  From the beginning of sedation to discharge from ICU, up to 28 days.

• Blood pressure

  From the beginning to weaning of sedation, up to 7 days.

• Cost of sedation drug

  From the admition to discharge from ICU,up to 28 days.

• Cost of narcotics

  From the admition to discharge from ICU,up to 28 days.

• Cost of ICU stay

  From the beginning to weaning of sedation, up to 7 days.

Study Arms (2)

Propofol/Dexmedetomidine

EXPERIMENTAL

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.

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

Midazolam/Dexmedetomidine

EXPERIMENTAL

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.

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

Interventions

Fentanyl DRUG

Fentanyl 0.7-1μg/kg，prn pain assessment is done every 4 hours，maintain Behavioral Pain Scale（BPS） 0-2.

Midazolam/Dexmedetomidine; Propofol/Dexmedetomidine

Sedation assessment PROCEDURE

Sedation assessment is done every 4 hours,maintain the Riker Sedation Agitation Score(SAS) 3-4.

Midazolam/Dexmedetomidine; Propofol/Dexmedetomidine

Screen of weaning PROCEDURE

1\. Screen of weaning is done at 8:00 every morning. 2 If the patient is successful to wean, stop the Dexmedetomidine sedation. 3. If failed to wean, the patient is ventilated again and try to wean after 24 hours, until it is successful to wean and stop sedation，

Midazolam/Dexmedetomidine; Propofol/Dexmedetomidine

Propofol DRUG

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.

Propofol/Dexmedetomidine

Midazolam DRUG

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.

Also known as: Liyuexi

Midazolam/Dexmedetomidine

Dexmedetomidine DRUG

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.

Also known as: Yisi

Midazolam/Dexmedetomidine; Propofol/Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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；
• Heart rate less than 50 bpm
• Second or third degree heart block
• Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia)
• Acute hepatitis or severe liver disease (Child-Pugh class C)
• Dialysis of all types 7）History of neuromuscular disease
• \) 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 -

Sponsors & Collaborators

• Tianjin Third Central Hospital: lead
• Chinese Medical Association: collaborator

MeSH Terms

Interventions

Fentanyl; Propofol; Midazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles

Study Officials

• Jun Li, Professor

  Tianjin Third Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 24, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 24, 2014

Record last verified: 2014-04