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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-22

Study Completion Date

2024-09-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Systemic Inflammatory Response Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Randomization and study drug preparation by person(s) not involved in patient care, data gathering or outcome evaluation. Group allocation kept in sealed opaque envelope until all data gathered.

Study Groups

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Saline

Continuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion

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

Group Type EXPERIMENTAL

Dexmedetomidine 0.5mcg/kg/h

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Dexmedetomidine 1 mcg/kg/h

Intervention Type DRUG

Continuous infusion of dexmedetomidine in 1mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion

Interventions

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Placebo

Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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saline dexmedetomidine in 0.5mcg/kg/h dose dexmedetomidine in 1 mcg/kg/h dose

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No