Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Anesthetics; Cardiopulmonary Bypass; Anesthetics, Intravenous; Pharmacology

Treatments: Drug: Ultiva; Drug: Remiva

Study type: Interventional

Funder types: Other

Identifiers

NCT02566733

Remifentanil_CPB

Details and patient eligibility

About

Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is performed using the Minto model. It was derived from patients undergoing general surgery. However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The investigators tested whether Minto model for target controlled infusion produces constant plasma remifentanil concentration during the cardiac surgery.

Enrollment: 56 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with the ASA class I~III undergoing elective cardiac surgery using cardiopulmonary bypass

Exclusion criteria

• Patients not using target controlled infusion during the operation
• Patients with drug/substance abuse
• Patients using analgesics before this study starts
• Pregnant women
• Patients who rejected study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Remiva

Experimental group

Description:

This experimental group will use a generic drug of remifentanil, Remiva™ from Hana Pharmaceutical company.

Treatment:

Drug: Remiva

Ultiva

Active Comparator group

Description:

This arm group will use a brand-named drug of remifentanil, Ultiva™ from GlaxoSmithKline company.

Treatment:

Drug: Ultiva