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

NCT05641064 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Systemic Inflammatory Response
  • Aortic Valve Stenosis

Interventions

DRUG

Placebo

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

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

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

Sponsors & Collaborators

  • University Hospital Dubrava

    lead OTHER

Principal Investigators

  • Zrinka Safaric Oremus, MD · UH Dubrava

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2024-09-22
Completion
2024-09-22

Countries

  • Croatia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641064 on ClinicalTrials.gov