Study Results
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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COMPLETED
NA
224 participants
INTERVENTIONAL
2021-07-07
2025-01-07
Brief Summary
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Recent experimental studies showed a possibility that dexmedetomidine may have an organoprotective effect from ischemic-reperfusion injury by reducing inflammatory response. Besides, dexmedetomidine is known to be related with attenuated sympathetic tone and improved microcirculation.
Taken together, it is plausible that dexmedetomidine exerts cardioprotection in patients undergoing cardiac surgery with cardiopulmonary bypass and aortic cross-clamp.
The aim of this trial is to test the effect of dexmedetomidine on postoperative cardiac troponin I measurements in patients undergoing cardiac surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Control
Placebo group using normal saline infusion
Control
During the same time window for dexmedetomidine, normal saline is infused at the same rate calculated for dexmedetomidine.
Dexmedetomidine
From anesthesia induction before the initiation of cardiopulmonary bypass, dexmedetomidine is infused intravenously at a rate of 0.5 mcg/kg/hr after a loading dose infusion of 0.75 mcg/kg for 10 mins.
Dexmedetomidine
Anesthesia is induced using midazolam or etomidate, and sufentanil. A target-controlled infusion of propofol and remifentanil is used for anesthesia maintenance.
From anesthesia induction before the initiation of cardiopulmonary bypass, dexmedetomidine is infused intravenously at a rate of 0.5 mcg/kg/hr after a loading dose infusion of 0.75 mcg/kg for 10 mins.
Interventions
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Dexmedetomidine
Anesthesia is induced using midazolam or etomidate, and sufentanil. A target-controlled infusion of propofol and remifentanil is used for anesthesia maintenance.
From anesthesia induction before the initiation of cardiopulmonary bypass, dexmedetomidine is infused intravenously at a rate of 0.5 mcg/kg/hr after a loading dose infusion of 0.75 mcg/kg for 10 mins.
Control
During the same time window for dexmedetomidine, normal saline is infused at the same rate calculated for dexmedetomidine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Concomitant cryo-Maze procedure
* Myectomy
* Heart transplantation
* Concomitant major non-cardiac surgery
* Isolated complicated congenital heart surgery
* descending thoracic aorta surgery with partial cardiopulmonary bypass
* Emergency surgery
* Minimally invasive or robot-assisted surgery
* Estimated GFR \<30 ml/min/1.73 m2
* Documented end-stage renal disease
* Preoperative renal replacement therapy
* Preoperative history of percutaneous coronary intervention within 6 month before surgery
* Acute coronary syndrome within 4 weeks before surgery
* Preoperative mechanical circulatory support devices
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Karam Nam, MD
Clinical Assistant Professor
Principal Investigators
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Karam Nam, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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DEXCARD
Identifier Type: -
Identifier Source: org_study_id
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