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

Phase 3

Completed

• Conditions: Aortic Valve Stenosis; Systemic Inflammatory Response
• Interventions: Drug: Dexmedetomidine 1 mcg/kg/h; Drug: Placebo; Drug: Dexmedetomidine 0.5mcg/kg/h

• Registration Number: NCT05641064
• Lead Sponsor: University Hospital Dubrava

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.

Study Timeline

• Study First Submitted: 2022-11-02
• Study Start: 2022-11-22
• Study First Submitted QC: 2022-12-04
• Study First Posted: 2022-12-07
• Primary Completion: 2024-09-22
• Study Completion: 2024-09-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine 1	Dexmedetomidine 1 mcg/kg/h	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
Saline	Placebo	Continuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
Dexmedetomidine 0.5	Dexmedetomidine 0.5mcg/kg/h	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

Primary Outcome Measures

Name	Time	Method
interleukin 6	24 hours preoperatively up to 12 hours post CPB	Concentration of IL-6 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3)
tumor necrosis factor alpha	24 hours preoperatively up to 12 hours post CPB	Concentration of TNF-alpha 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3)

Secondary Outcome Measures

Name	Time	Method
Renal function - creatinine	From recruitment date up to 10 days postoperatively	Determining parameters of renal function: creatinine concentration
Renal function - urea	From recruitment date up to 10 days postoperatively	Determining parameters of renal function: urea concentration
Renal function - diuresis	From recruitment date up to 10 days postoperatively	Determining parameters of renal function: Daily 24-hour urine output in ml
Postoperative delirium	From recruitment date up to 30 days postoperatively	Determining incidence of postoperative delirium using Confusion Assessment Method questionaire
Renal function - diuretic consumption	From recruitment date up to 10 days postoperatively	Determining parameters of renal function: diuretic consumption
Renal function - GFR	From recruitment date up to 10 days postoperatively	Determining parameters of renal function: glomerular filtration rate
Inflammatory marker concentration during hospital stay	From recruitment date up to 30 days postoperatively	Determination of concentration of CRP and procalcitonin during hospital stay
Infection rate	From recruitment date up to 30 days postoperatively	Determining incidence of wound infection, pneumonia, urinary infection and sepsis during hospital stay
Analgesic and anesthetic consumption	From recruitment date up to 10 days postoperatively	Determining intraoperative anesthetic consumption (midazolam, sufentanil, propofol and sevoflurane) and postoperative analgesic use

Trial Locations

Locations (1)

University hospital Dubrava; 🇭🇷 Zagreb, Croatia