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

October 18, 2016 updated by: Tae Kyong Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remiva
This experimental group will use a generic drug of remifentanil, Remiva™ from Hana Pharmaceutical company.
Drug: Remiva
Target controlled infusion of remifentanil (generic drug, Remiva™)
Other Names:
  • generic drug of remifentanil, Remiva™
Active Comparator: Ultiva
This arm group will use a brand-named drug of remifentanil, Ultiva™ from GlaxoSmithKline company.
Drug: Ultiva
Target controlled infusion of remifentanil (brand-named drug, Ultiva™)
Other Names:
  • brand-named drug of remifentanil, Ultiva™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Median prediction error
Time Frame: during CPB
during CPB

Secondary Outcome Measures

Outcome Measure
Time Frame
changes of measured total remifentanil concentration
Time Frame: 1 hour after anesthesia induction, 30/60/90 min after the beginning of cardiopulmonary bypass, 1 hour after the end of cardiopulmonary bypass
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
Time Frame: during CPB
during CPB

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Tae Kyong Kim, MD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Remifentanil_CPB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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