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

Mechanical Ventilation Complication Clinical Trial

Official title:

Sequential Use of Propofol/Midazolam and Dexmedetomidine for Sedation in Mechenical Ventialtion Patients in ICU, A Randomized Controlled Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02122055
• Other study ID #: CMATJHICU
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 21, 2014
• Last updated: April 22, 2014
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2014
• Source: Tianjin Third Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

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

Procedure:
• Sedation assessment
Sedation assessment is done every 4 hours,maintain the Riker Sedation Agitation Score(SAS) 3-4.
• Screen of weaning
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,

Drug:
• Propofol
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.
• Midazolam
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.
• Dexmedetomidine
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Third Central Hospital	Chinese Medical Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Delirium	Using the Mini-mental State Examination(MMSE) to examine the delirium.	From the beginning of sedation to discharge from ICU, up to 28 days.	Yes
Secondary	Blood pressure	blood pressure is recorded.	From the beginning to weaning of sedation, up to 7 days.	Yes
Secondary	Cost of sedation drug	The cost of sedation drug is calculated.	From the admition to discharge from ICU,up to 28 days.	No
Secondary	Cost of narcotics	Cost of narcotics is calculated.	From the admition to discharge from ICU,up to 28 days.	No
Secondary	Cost of ICU stay		From the beginning to weaning of sedation, up to 7 days.	No
Secondary	Heart rate		From the beginning to weaning of sedation, up to 7 days.	Yes
Secondary	Respiration Rate		From the beginning to weaning of sedation, up to 7 days.	Yes
Secondary	Pulse blood oxygen saturation		From the beginning to weaning of sedation, up to 7 days.	Yes