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CompletedNCT05451121Updated Jul 11, 2022

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

An interventional study of Propofol and Dexmedetomidine in Respiratory Failure, Mechanical Ventilation Complication and Sedation Complication, sponsored by Anesthesia Research Group UA. Completed at 1 site in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-11.

Sponsored by Anesthesia Research Group UA · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 11 months after the study started (first participant enrolled Jul 2017, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
356
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Respiratory Failure
  • Mechanical Ventilation Complication
  • Sedation Complication

Keywords

  • LOHS, sedation, cardiac surgery, intensive care unit
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In context

Respiratory Insufficiency

1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.

This study's enrollment of 356 is above the median of 55 across 1,056 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Anesthesia Research Group UA is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
356 participants (actual)

Study arms

  • Experimental
    propofol

    Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol (hypnotic agent) using a syringe pump at the dose of 1-1.5 mg / kg / h

    Drug: Propofol

  • Experimental
    Dexmedetomidine

    Patient sedation after cardiac surgery at the intensive care unit. continuous infusion of Dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h

    Drug: Dexmedetomidine

  • Experimental
    propofol and dexmedetomidine

    Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol using a syringe pump at the dose of 0.5-1.5 mg / kg / h and dexmedetomidine 0.2-0.7 mcg\\kg\\h

    Drug: Propofol and dexmedetomidine

Interventions

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

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

  • DrugPropofol and dexmedetomidine

    Drug pages: Propofol · Dexmedetomidine

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

06

What researchers measure

Primary outcomes

  1. length of the mechanical ventilation

    measure the length of the mechanical ventilation

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

Secondary outcomes

  1. Length of the ICU stay

    thе amount of the days spent in the ICU

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

  2. Length of the hospital stay

    thе amount of the days spent in the hospital

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

07

Study locations

1 site
  • Anesthesia department Medical Network Dobrobut
    Kyiv, 01000, Ukraine
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05451121
Lead sponsor
Anesthesia Research Group UA
Responsible party
Plechysta Yelyzaveta (Chief of the anesthesia department, Anesthesia Research Group UA) — Principal investigator
First posted
Jul 11, 2022
Start date
Jul 1, 2017
Primary completion
Jul 1, 2019
Completion
Jul 1, 2019
Last update
Jul 11, 2022

Study contacts

Yelyzaveta Plechysta
study chair · Chief of the anesthesia department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Propofol · Dexmedetomidine

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