Clinical trial NCT05451121: Effect of Sedation Strategy on Duration Mechanical Ventilation in Patient After Cardiac Surgery
Official title: Comparing Effect of Propofol, Dexmedetomidine and Their Combination on Duration Mechanical Ventilation in Patient After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Mechanical Ventilation Complication
Sedation Complication
Keywords: LOHS, sedation, cardiac surgery, intensive care unit
Lead sponsor: Anesthesia Research Group UA
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: length of the mechanical ventilation
timeFrame: after cardiac surgery till extubation (up to first 24 hour after surgery)
Secondary outcomes:
measure: Length of the ICU stay
timeFrame: at the day of discharge of ICU (assessed up to day 5)
measure: Length of the hospital stay
timeFrame: at the day of discharge of hospital (assessed up to day 5)
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Anesthesia department Medical Network Dobrobut
Study officials:
affiliation: Chief of the anesthesia department
name: Yelyzaveta Plechysta
role: STUDY_CHAIR
References: