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

University Hospital Dubrava

Status and phase: Completed; Phase 3

Conditions: Aortic Valve Stenosis; Systemic Inflammatory Response

Treatments: Drug: Dexmedetomidine 1 mcg/kg/h; Drug: Placebo; Drug: Dexmedetomidine 0.5mcg/kg/h

Study type: Interventional

Funder types: Other

Identifiers

NCT05641064

78Z11053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Dexmedetomidine 0.5

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine 0.5mcg/kg/h

Dexmedetomidine 1

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine 1 mcg/kg/h