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

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

Evaluation of Intraoperative Dexmedetomidine Use on Reducing Inflammatory Response Caused by Cardiopulmonary Bypass 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.

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.

Randomization and study drug preparation by person(s) not involved in patient care, data gathering or outcome evaluation. Group allocation kept in sealed opaque envelope until all data gathered.

Continuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery

Continuous infusion of dexmedetomidine in dose 0.5 mcg/kg/min starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery

Continuous infusion of dexmedetomidine in dose 1 mcg/kg/min starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery

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

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

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

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

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

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

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

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

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Bulow NM, Colpo E, Pereira RP, Correa EF, Waczuk EP, Duarte MF, Rocha JB. Dexmedetomidine decreases the inflammatory response to myocardial surgery under mini-cardiopulmonary bypass. Braz J Med Biol Res. 2016;49(4):e4646. doi: 10.1590/1414-431X20154646. Epub 2016 Feb 23.

Lee JM, Han HJ, Choi WK, Yoo S, Baek S, Lee J. Immunomodulatory effects of intraoperative dexmedetomidine on T helper 1, T helper 2, T helper 17 and regulatory T cells cytokine levels and their balance: a prospective, randomised, double-blind, dose-response clinical study. BMC Anesthesiol. 2018 Nov 8;18(1):164. doi: 10.1186/s12871-018-0625-2.