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Completed

NCT Number: NCT05450497

Effect of Sedative Agent on Reducing the Frequency of Arrhythmia in the Patients After Cardiac Surgery

Arrhythmias early in the recovery period after cardio thoracic surgery are common they develop in 11 to 40 percent of patients after coronary-artery bypass grafting. The right chose of sedative agent could decrease the level of arrhythmia incidence.

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Key information

Conditions

Arrythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

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

Arrhythmias are really common in patients after cardiac surgery. Most of the patients get sedation after cardiac surgery. The goal is to determine if the propofol (PR) (sedative agent), dexmedetomidine (DEX)(selective α2-adrenergic receptor (α2-AR) agonist) or their combination could improve and decrease the incidence of the arrhythmia in patients after cardiac surgery.

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)
  • Age of patients from 18-80 years;

Exclusion criteria

  • Refusal to participate;
  • Hypersensitivity to propofol, dexmedetomidine;
  • 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)

Treatment and study plan

Propofol

Drug

comparing sedative agents

Dexmedetomidine

Drug

comparing sedative agents

Dexmedetomidine and propofol

Drug

comparing sedative agents

Primary outcomes

  1. incidence of arrhythmia

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

    incidence of deviation from the rhythm before the surgery and at the day of the discharge from the hospital after cardia surgery

Sponsors and collaborators

Lead sponsor

Anesthesia Research Group UA

Other

Registry information

Official study title

Effect of Propofol vs Dexmedetomidine or Propofol+Dexmedetomidine on Reducing the Frequency of Arrhythmia in Patients After Cardiac Surgery

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2022
Registry last updated
Jul 8, 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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