Respiratory Failure, Mechanical Ventilation Complication, Sedation Complication
Conditions
Keywords
LOHS, sedation, cardiac surgery, intensive care unit
Brief summary
There is a direct relationship between the sedative agent and the duration of ventilation.
Detailed description
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.
Interventions
DRUGPropofol
patient sedation with a propofol (sedative agent) after cardiac surgery
DRUGDexmedetomidine
patient sedation with dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) after cardiac surgery
Patients sedation with a drug combination: propofol and dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist)
Sponsors
Anesthesia Research Group UA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of the mechanical ventilation | after cardiac surgery till extubation (up to first 24 hour after surgery) | measure the length of the mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of the ICU stay | at the day of discharge of ICU (assessed up to day 5) | thе amount of the days spent in the ICU |
| Length of the hospital stay | at the day of discharge of hospital (assessed up to day 5) | thе amount of the days spent in the hospital |
Countries
Ukraine
Outcome results
None listed