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Completed

NCT Number: NCT05451121

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

There is a direct relationship between the sedative agent and the duration of ventilation.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesia department Medical Network Dobrobut

Kyiv, 01000, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

patient sedation with a propofol (sedative agent) after cardiac surgery

Dexmedetomidine

Drug

patient sedation with dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) after cardiac surgery

Propofol and dexmedetomidine

Drug

Patients sedation with a drug combination: propofol and dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist)

Primary outcomes

  1. length of the mechanical ventilation

    Time frame: after cardiac surgery till extubation (up to first 24 hour after surgery)

    measure the length of the mechanical ventilation

Secondary outcomes

  1. Length of the ICU stay

    Time frame: at the day of discharge of ICU (assessed up to day 5)

    thе amount of the days spent in the ICU

  2. Length of the hospital stay

    Time frame: at the day of discharge of hospital (assessed up to day 5)

    thе amount of the days spent in the hospital

Sponsors and collaborators

Lead sponsor

Anesthesia Research Group UA

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2022
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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