Sedative Adverse Reaction, Sedation Complication, Hemodynamic Instability, Agitation on Recovery From Sedation, Respiratory Complication
Conditions
Brief summary
Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use.
Detailed description
Sedating a patient is a complex process, especially after heart surgery. Sedation has a negative hemodynamic effect. This leads to a decrease in blood pressure and increases the frequency and dose of vasopressors used. The choice of drug for sedation may have an impact on reducing the frequency of use of vasopressor therapy. The goal of the research is compare three strategies: propofol ( sedative agent), dexmedetomidine ( selective α2-adrenergic receptor (α2-AR) agonist that is associated with sedative effect) and their combination for sedation after cardiac surgery.
Interventions
DRUGPropofol
sedation after cardiac surgery
DRUGDexmedetomidine
sedation after cardiac surgery
sedation after cardiac surgery
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 heart ultrasound, 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; * Women who have a negative pregnancy test and use effective contraception throughout the study and for 3 weeks after its completion, or women who are unable to have children (women who have undergone a hysterectomy (removal of the uterus) or tubal ligation, women with a clinical diagnosis of infertility) or are menopausal for more than 1 year (absence of menstruation for at least 12 months). Adequate methods of contraception include: surgical sterilization, double barrier method of contraception, local contraception;
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; * Gastric or duodenal ulcer with risk of bleeding; * 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 |
|---|---|---|
| vasopressor requirements | every hour during sedation(up to 12 hours) | incidence of cases of using norepinephrine. measurement tool is a fact of using that is marked as yes\\no in the check-list |
| dose of norepinephrine | every hour during sedation (up to 12 hours) | measure the maximum dose of norepinephrine in mcg\\kg\\min to achieve mean arterial pressure 70 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in the ICU | before discharging from ICU to the ward ( up to 3 days) | measure at days |
Countries
Ukraine
Outcome results
None listed