CompletedPhase 3

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

Croatia60 participantsStarted 2022-11-22

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

interleukin 6

Timeframe: 24 hours preoperatively up to 12 hours post CPB

tumor necrosis factor alpha

Timeframe: 24 hours preoperatively up to 12 hours post CPB

Trial details

NCT IDNCT05641064

SponsorUniversity Hospital Dubrava

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-22

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