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NCT Number: NCT05641064

Evaluation of Intraoperative Dexmedetomidine Use in Patients Undergoing Surgical Aortic Valve Replacement

Aim of this randomized prospective study is to investigate the immunomodulatory effects of dexmedetomidine on outcomes in patients with isolated aortic stenosis after surgical aortic valve replacement.

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Key information

Conditions

Systemic Inflammatory Response Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University hospital Dubrava

Zagreb, 10000, Croatia

About this study

Study will investigate effects of two different doses of dexmedetomidine on concentrations of tumor necrosis factor-α and interleukin-6, on inflammatory parameters (C reactive protein and procalcitonin) and inflammatory complications, renal function, postoperative delirium, anaesthetic and analgetic consumption and compare it to control group. It should provide a better understanding of dexmedetomidine effect on decrease of inflammatory response in patients undergoing cardiac surgery. Short-term infusion of dexmedetomidine could reduce inflammatory postoperative complications, contribute to improvement of perioperative renal function and occurrence of postoperative delirium, supporting recovery and shortening hospital stay.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • isolated aortic stenosis adult patients with written consent

Exclusion criteria

  • BMI <30kg/m2
  • 1st, 2nd and 3rd degree AV block
  • bradycardia HR<50/min upon arrival to operating theatre
  • neurological disorders (Parkinson's disease, Myasthenia gravis, multiple sclerosis, brain tumors in anamnesis)
  • recent use of psychoactive drugs
  • alcohol and illicit drug addiction
  • diabetes type I with complications
  • patients who develop hypotension after initiation of dexmedetomidine infusion requiring vasoconstriction therapy
  • patients receiving corticosteroids in perioperative period
  • patients with known allergy to dexmedetomidine

Treatment and study plan

Placebo

Drug

Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion

Other names: saline

Dexmedetomidine 0.5mcg/kg/h

Drug

Continuous infusion of dexmedetomidine in 0.5mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion

Other names: dexmedetomidine in 0.5mcg/kg/h dose

Dexmedetomidine 1 mcg/kg/h

Drug

Continuous infusion of dexmedetomidine in 1mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion

Other names: dexmedetomidine in 1 mcg/kg/h dose

Primary outcomes

  1. interleukin 6

    Time frame: 24 hours preoperatively up to 12 hours post CPB

    Concentration of IL-6 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3)

  2. tumor necrosis factor alpha

    Time frame: 24 hours preoperatively up to 12 hours post CPB

    Concentration of TNF-alpha 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3)

Secondary outcomes

  1. Inflammatory marker concentration during hospital stay

    Time frame: From recruitment date up to 30 days postoperatively

    Determination of concentration of CRP and procalcitonin during hospital stay

  2. Infection rate

    Time frame: From recruitment date up to 30 days postoperatively

    Determining incidence of wound infection, pneumonia, urinary infection and sepsis during hospital stay

  3. Renal function - diuresis

    Time frame: From recruitment date up to 10 days postoperatively

    Determining parameters of renal function: Daily 24-hour urine output in ml

  4. Renal function - diuretic consumption

    Time frame: From recruitment date up to 10 days postoperatively

    Determining parameters of renal function: diuretic consumption

  5. Renal function - GFR

    Time frame: From recruitment date up to 10 days postoperatively

    Determining parameters of renal function: glomerular filtration rate

  6. Renal function - creatinine

    Time frame: From recruitment date up to 10 days postoperatively

    Determining parameters of renal function: creatinine concentration

  7. Renal function - urea

    Time frame: From recruitment date up to 10 days postoperatively

    Determining parameters of renal function: urea concentration

  8. Postoperative delirium

    Time frame: From recruitment date up to 30 days postoperatively

    Determining incidence of postoperative delirium using Confusion Assessment Method questionaire

  9. Analgesic and anesthetic consumption

    Time frame: From recruitment date up to 10 days postoperatively

    Determining intraoperative anesthetic consumption (midazolam, sufentanil, propofol and sevoflurane) and postoperative analgesic use

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Official study title

Evaluation of Intraoperative Dexmedetomidine Use on Reducing Inflammatory Response Caused by Cardiopulmonary Bypass in Patients Undergoing Surgical Aortic Valve Replacement

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2022
Registry last updated
Mar 30, 2025

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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