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Completed

NCT Number: NCT05809518

Influence of Sedation Strategies on Hospital LOS and ICU LOS in Patients Cardiac Surgery

Preoperative, intraoperative and postoperative management of the patient are some of the main stages that can affect the hospital LOS and ICU LOS. Experience on the evidence-based approach and the progressive guidelines implementation of recommendations, the issue of the choice of drugs for sedation in the family and their impact on the length of stay in the intensive care unit and the length of hospitalization remain unsolved.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Network Dobrobut

Kyiv, 01000, Ukraine

About this study

Optimization of sedation regimes can become one of the factors that will help to reduce the length of hospital and ICU stay. The purpose of the study is to track is there a relationship between the drug for sedation and the length of stay of patients in the intensive care unit and in hospital treatment.

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 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)
  • 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.

Treatment and study plan

Propofol Injection

Drug

sedation after cardiac surgery

Other names: Pr

Dexmedetomidine Injection

Drug

sedation after cardiac surgery

Other names: Dx

Dexmedetomidine and propofol

Drug

sedation after cardiac surgery

Other names: DxPr

Primary outcomes

  1. hospital LOS

    Time frame: from admission to discharge ( up to 20 days)

    measure at days

  2. ICU LOS

    Time frame: before discharging from ICU to the ward ( up to 7 days)

    measure at days

Secondary outcomes

  1. difference in ICU LOS in patients with vasopressors and without vasopressors

    Time frame: before discharging from ICU to the ward ( up to 7 days

    measure at days

Other outcomes

  1. difference in hospital LOS in patients with vasopressors and without vasopressors

    Time frame: from admission to discharge ( up to 20 days)

    measure at days

Sponsors and collaborators

Lead sponsor

Anesthesia Research Group UA

Other

Registry information

Official study title

Influence of Sedation Strategies on Hospital LOS and ICU LOS in Patients After Cardiac Surgery With Cardiac Pulmonary Bypass. Comparison of Propofol-based, Dexmedetomidine-based Sedation or Their Combination.

Acronym: LOS

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

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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