Dexmedetomidine in Pediatric Cardiac Surgery

Seoul National University

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Drug: normal saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02888275

H1608-052-784

Details and patient eligibility

About

Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary profile that makes it an attractive anesthetic for pediatric patients with congenital heart disease (CHD). The aim of this study was to investigate the renal protective effect of dexmedetomidine in the perioperative setting in children with heart disease.

Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug (NoDEX) group.

The primary objective of this study was to assess the relationship between the use of intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients undergoing cardiopulmonary bypass. The secondary objective was to determine whether there was an association between dexmedetomidine use and duration of mechanical ventilation or cardiovascular ICU stay.

Enrollment: 144 patients

Sex: All

Ages: Under 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing congenital cardiac surgery

Exclusion criteria

• history of allergy or anaphylaxis to study drug
• preexisting renal dysfunction (preoperative creatinine >1.5mg/dl)
• diabetes
• liver profile abnormality

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups

DEX

Experimental group

Description:

dexmedetomidine 1mcg/kg for 10min. loading and continuous infusion during the surgery 0.5mcg/kg/hr.

Treatment:

Drug: Dexmedetomidine

no_DEX

Active Comparator group

Description:

Normal saline 1mcg/kg for 10min. and continuous infusion during the surgery 0.5mcg/kg/hr.

Treatment:

Drug: normal saline