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 range

18 Years – 85 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Systemic Inflammatory Response trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

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