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

Aortic Valve Stenosis Clinical Trial

Official title:

Evaluation of Intraoperative Dexmedetomidine Use on Reducing Inflammatory Response Caused by Cardiopulmonary Bypass in Patients Undergoing Surgical Aortic Valve Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641064
• Other study ID #: 78Z11053
• Status: Recruiting
• Phase: Phase 3
• Start date: November 22, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: University Hospital Dubrava
• Contact: Zrinka Safaric Oremus, MD
• Phone: +38598242538
• Email: zsafarico[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Systemic Inflammatory Response

Intervention

Drug:
• Placebo
Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
• Dexmedetomidine 0.5mcg/kg/h
Continuous infusion of dexmedetomidine in 0.5mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
• Dexmedetomidine 1 mcg/kg/h
Continuous infusion of dexmedetomidine in 1mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion

Locations

Country	Name	City	State
Croatia	University hospital Dubrava	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interleukin 6	Concentration of IL-6 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3)	24 hours preoperatively up to 12 hours post CPB
Primary	tumor necrosis factor alpha	Concentration of TNF-alpha 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3)	24 hours preoperatively up to 12 hours post CPB
Secondary	Inflammatory marker concentration during hospital stay	Determination of concentration of CRP and procalcitonin during hospital stay	From recruitment date up to 30 days postoperatively
Secondary	Infection rate	Determining incidence of wound infection, pneumonia, urinary infection and sepsis during hospital stay	From recruitment date up to 30 days postoperatively
Secondary	Renal function - diuresis	Determining parameters of renal function: Daily 24-hour urine output in ml	From recruitment date up to 10 days postoperatively
Secondary	Renal function - diuretic consumption	Determining parameters of renal function: diuretic consumption	From recruitment date up to 10 days postoperatively
Secondary	Renal function - GFR	Determining parameters of renal function: glomerular filtration rate	From recruitment date up to 10 days postoperatively
Secondary	Renal function - creatinine	Determining parameters of renal function: creatinine concentration	From recruitment date up to 10 days postoperatively
Secondary	Renal function - urea	Determining parameters of renal function: urea concentration	From recruitment date up to 10 days postoperatively
Secondary	Postoperative delirium	Determining incidence of postoperative delirium using Confusion Assessment Method questionaire	From recruitment date up to 30 days postoperatively
Secondary	Analgesic and anesthetic consumption	Determining intraoperative anesthetic consumption (midazolam, sufentanil, propofol and sevoflurane) and postoperative analgesic use	From recruitment date up to 10 days postoperatively