Evaluation of Intraoperative Dexmedetomidine Use on Reducing Inflammatory Response Caused by Cardiopulmonary Bypass in Patients Undergoing Surgical Aortic Valve Replacement
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Systemic Inflammatory Response
- Sponsor
- University Hospital Dubrava
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- interleukin 6
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Zrinka Safaric Oremus
Principal Investigator
University Hospital Dubrava
Eligibility Criteria
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
Arms & Interventions
Saline
Continuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
Intervention: Placebo
Dexmedetomidine 0.5
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
Intervention: Dexmedetomidine 0.5mcg/kg/h
Dexmedetomidine 1
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
Intervention: Dexmedetomidine 1 mcg/kg/h
Outcomes
Primary Outcomes
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)
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
- Renal function - creatinine(From recruitment date up to 10 days postoperatively)
- Renal function - urea(From recruitment date up to 10 days postoperatively)
- Renal function - diuretic consumption(From recruitment date up to 10 days postoperatively)
- Renal function - GFR(From recruitment date up to 10 days postoperatively)
- Renal function - diuresis(From recruitment date up to 10 days postoperatively)
- Postoperative delirium(From recruitment date up to 30 days postoperatively)
- Inflammatory marker concentration during hospital stay(From recruitment date up to 30 days postoperatively)
- Infection rate(From recruitment date up to 30 days postoperatively)
- Analgesic and anesthetic consumption(From recruitment date up to 10 days postoperatively)