Evaluation of Intraoperative Dexmedetomidine Use in Patients Undergoing Surgical Aortic Valve Replacement
Key facts
- Who runs it
- University Hospital Dubrava
- Where
- Croatia1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 60 people enrolled
- Started
- 22 Nov 2022
- Ended
- 22 Sept 2024
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- Dexmedetomidine 0.5mcg/kg/h
- Dexmedetomidine 1 mcg/kg/h
- Record updated
- 30 March 2025
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- isolated aortic stenosis adult patients with written consent
Who cannot take part
- recent use of psychoactive drugs
- alcohol and illicit drug addiction
- patients who develop hypotension after initiation of dexmedetomidine infusion requiring vasoconstriction therapy
- patients receiving corticosteroids in perioperative period
- neurological disorders (Parkinson's disease, Myasthenia gravis, multiple sclerosis, brain tumors in anamnesis)
- diabetes type I with complications
- patients with known allergy to dexmedetomidine
- BMI <30kg/m2
- 1st, 2nd and 3rd degree AV block
- bradycardia HR<50/min upon arrival to operating theatre
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- SalinePlacebo, for comparison
Continuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
Treatment: Placebo
- Dexmedetomidine 0.5Treatment being tested
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: Dexmedetomidine 0.5mcg/kg/h
- Dexmedetomidine 1Treatment being tested
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: Dexmedetomidine 1 mcg/kg/h
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Intraoperative Dexmedetomidine Use on Reducing Inflammatory Response Caused by Cardiopulmonary Bypass in Patients Undergoing Surgical Aortic Valve Replacement
- Record updated
- 30 March 2025