Effect of Sedation Strategy on Duration Mechanical Ventilation in Patient After Cardiac Surgery

Study Overview
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Brief Summary
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There is a direct relationship between the sedative agent and the duration of ventilation.

Detailed Description
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Sedation and sedative agent have direct correlation to the mechanical length. As known mechanical length could increase length of the hospital stay (LOHS) and mortality rate. The right sedative agent can decrease the length go the mechanical ventilation. The goal of the research to compare 3 sedation strategies and their influence to the duration of mechanical ventilation.

Official Title
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Comparing Effect of Propofol, Dexmedetomidine and Their Combination on Duration Mechanical Ventilation in Patient After Cardiac Surgery

Conditions
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Respiratory Failure, Mechanical Ventilation Complication, Sedation Complication

Intervention / Treatment
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* Drug: Propofol
* Drug: Dexmedetomidine
* Drug: Propofol and dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multi vascular lesions of the coronary arteries according to coronary angiography; Heart valve damage was confirmed by, which is subject to surgical correction (aortic stenosis of III degree with a gradient on the aortic valve of more than 42 mmHg, aortic insufficiency III, mitral valve stenosis II-III, mitral regurgitation II-III) Age of patients from 18-80 years; • Patient consent to participate in the study; Exclusion Criteria: Refusal to participate; Hypersensitivity to propofol, dexmedetomidine; Prolonged mechanical ventilation in case of surgical complications (bleeding, inadequate perfusion of the myocardium); Occurred ischemic stroke; History of the ischemic stroke; History of the neurodegenerative diseases; History of the mental disorders; Use of neuroleptics, antidepressants for the last 5 years; History of the cardiac surgery in the past; Patients with chronic pulmonary disease (GOLD 3-4) Patients with asthma (moderate or severe), Participation in any other clinical trial; Chronic renal failure (ClCr less than 50 ml / h) Acute renal failure that occurred during surgery (ClCr less than 50 ml / h, or a decrease in the rate of diuresis to 0.1 ml / h in the first 4 hours after surgery and does not respond to diuretic therapy) Chronic hepatic insufficiency if there are laboratory signs of hypo coagulation without the use of anticoagulant therapy (INR> 1.5) If the patient has not stopped taking anticoagulants or antiplatelet agents in the preoperative period: warfarin 5 days before surgery, clopidogrel 5-7 days before surgery, xarelto / pradaxa 3 days before surgery), History of the hematological disease; Alcohol abuse in the anamnesis (3-4 times a week). Condition after chemotherapy; Pregnancy, lactation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol<br>Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol (hypnotic agent) using a syringe pump at the dose of 1-1.5 mg / kg / h | Drug: Propofol<br>* patient sedation with a propofol (sedative agent) after cardiac surgery<br>|
| Experimental: Dexmedetomidine<br>Patient sedation after cardiac surgery at the intensive care unit. continuous infusion of Dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h | Drug: Dexmedetomidine<br>* patient sedation with dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) after cardiac surgery<br>|
| Experimental: propofol and dexmedetomidine<br>Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol using a syringe pump at the dose of 0.5-1.5 mg / kg / h and dexmedetomidine 0.2-0.7 mcg\kg\h | Drug: Propofol and dexmedetomidine<br>* Patients sedation with a drug combination: propofol and dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of the mechanical ventilation | measure the length of the mechanical ventilation | after cardiac surgery till extubation (up to first 24 hour after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of the ICU stay | thе amount of the days spent in the ICU | at the day of discharge of ICU (assessed up to day 5) | 
| Length of the hospital stay | thе amount of the days spent in the hospital | at the day of discharge of hospital (assessed up to day 5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LOHS, sedation, cardiac surgery, intensive care unit