Overview

Vasopressor Requirements Depends on Sedation Strategy

Status:
Completed
Trial end date:
2022-05-29
Target enrollment:
0
Participant gender:
All
Summary
Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Anesthesia Research Group UA
Treatments:
Dexmedetomidine
Propofol
Criteria
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.