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

NCT ID: NCT02566733

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-06-30

Brief Summary

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.

Conditions

Anesthetics, Intravenous; Pharmacology; Anesthetics; Cardiopulmonary Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Remiva

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

Group Type: EXPERIMENTAL

Remiva

Intervention Type: DRUG

Target controlled infusion of remifentanil (generic drug, Remiva™)

Ultiva

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

Group Type: ACTIVE_COMPARATOR

Ultiva

Intervention Type: DRUG

Target controlled infusion of remifentanil (brand-named drug, Ultiva™)

Interventions

Remiva

Target controlled infusion of remifentanil (generic drug, Remiva™)

Intervention Type: DRUG

Ultiva

Target controlled infusion of remifentanil (brand-named drug, Ultiva™)

Intervention Type: DRUG

Other Intervention Names

generic drug of remifentanil, Remiva™; brand-named drug of remifentanil, Ultiva™

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tae Kyong Kim

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tae Kyong Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

Remifentanil_CPB

Identifier Type: -

Identifier Source: org_study_id