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

March 25, 2025 updated by: Zrinka Safaric Oremus, University Hospital Dubrava

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Dubrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Continuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
Drug: Placebo
Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Other Names:
  • saline
Experimental: Dexmedetomidine 0.5
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
Drug: 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
Other Names:
  • dexmedetomidine in 0.5mcg/kg/h dose
Experimental: Dexmedetomidine 1
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
Drug: 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
Other Names:
  • dexmedetomidine in 1 mcg/kg/h dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interleukin 6
Time Frame: 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)
24 hours preoperatively up to 12 hours post CPB
tumor necrosis factor alpha
Time Frame: 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)
24 hours preoperatively up to 12 hours post CPB

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Dubrava

Investigators

  • Principal Investigator: Zrinka Safaric Oremus, MD, UH Dubrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2022

Primary Completion (Actual)

September 22, 2024

Study Completion (Actual)

September 22, 2024

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

December 4, 2022

First Posted (Actual)

December 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 78Z11053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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