Clinical trial NCT05641064: Evaluation of Intraoperative Dexmedetomidine Use in Patients Undergoing Surgical Aortic Valve Replacement
Official title: Evaluation of Intraoperative Dexmedetomidine Use on Reducing Inflammatory Response Caused by Cardiopulmonary Bypass in Patients Undergoing Surgical Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Inflammatory Response
Aortic Valve Stenosis
Keywords: dexmedetomidine
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: interleukin 6
timeFrame: 24 hours preoperatively up to 12 hours post CPB
measure: tumor necrosis factor alpha
timeFrame: 24 hours preoperatively up to 12 hours post CPB
Secondary outcomes:
measure: Inflammatory marker concentration during hospital stay
timeFrame: From recruitment date up to 30 days postoperatively
measure: Infection rate
timeFrame: From recruitment date up to 30 days postoperatively
measure: Renal function - diuresis
timeFrame: From recruitment date up to 10 days postoperatively
measure: Renal function - diuretic consumption
timeFrame: From recruitment date up to 10 days postoperatively
measure: Renal function - GFR
timeFrame: From recruitment date up to 10 days postoperatively
measure: Renal function - creatinine
timeFrame: From recruitment date up to 10 days postoperatively
measure: Renal function - urea
timeFrame: From recruitment date up to 10 days postoperatively
measure: Postoperative delirium
timeFrame: From recruitment date up to 30 days postoperatively
measure: Analgesic and anesthetic consumption
timeFrame: From recruitment date up to 10 days postoperatively
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University hospital Dubrava
Study officials:
affiliation: UH Dubrava
name: Zrinka Safaric Oremus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma Y, Yu XY, Wang Y. Dose-related effects of dexmedetomidine on immunomodulation and mortality to septic shock in rats. World J Emerg Med. 2018;9(1):56-63. doi: 10.5847/wjem.j.1920-8642.2018.01.009.
citation: Bulow NM, Colpo E, Pereira RP, Correa EF, Waczuk EP, Duarte MF, Rocha JB. Dexmedetomidine decreases the inflammatory response to myocardial surgery under mini-cardiopulmonary bypass. Braz J Med Biol Res. 2016;49(4):e4646. doi: 10.1590/1414-431X20154646. Epub 2016 Feb 23.
citation: Lee JM, Han HJ, Choi WK, Yoo S, Baek S, Lee J. Immunomodulatory effects of intraoperative dexmedetomidine on T helper 1, T helper 2, T helper 17 and regulatory T cells cytokine levels and their balance: a prospective, randomised, double-blind, dose-response clinical study. BMC Anesthesiol. 2018 Nov 8;18(1):164. doi: 10.1186/s12871-018-0625-2.