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

NCT02566733 | Completed Phase 4 DMC

• 1 other identifier: Remifentanil_CPB
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Keywords

remifentanil

Outcome Measures

Primary Outcomes (1)

• Median prediction error

  during CPB

Secondary Outcomes (2)

• changes of measured total remifentanil concentration

  1 hour after anesthesia induction, 30/60/90 min after the beginning of cardiopulmonary bypass, 1 hour after the end of cardiopulmonary bypass

• Median absolute prediction error

  during CPB

Study Arms (2)

Remiva

EXPERIMENTAL

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

Drug: Remiva

Ultiva

ACTIVE COMPARATOR

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

Drug: Ultiva

Interventions

Remiva DRUG

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

Also known as: generic drug of remifentanil, Remiva™

Remiva

Ultiva DRUG

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

Also known as: brand-named drug of remifentanil, Ultiva™

Ultiva

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tae Kyong Kim, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 2, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

KR (1)