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

Overview

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.

Full Title of Study: “Performance of the Minto Model in Effect Site Mode for Target Controlled Infusion of Remifentanil During Cardiopulmonary Bypass”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 2016

Interventions

  • Drug: Remiva
    • Target controlled infusion of remifentanil (generic drug, Remiva™)
  • Drug: Ultiva
    • Target controlled infusion of remifentanil (brand-named drug, Ultiva™)

Arms, Groups and Cohorts

  • Experimental: Remiva
    • This experimental group will use a generic drug of remifentanil, Remiva™ from Hana Pharmaceutical company.
  • Active Comparator: Ultiva
    • This arm group will use a brand-named drug of remifentanil, Ultiva™ from GlaxoSmithKline company.

Clinical Trial Outcome Measures

Primary Measures

  • Median prediction error
    • Time Frame: during CPB

Secondary Measures

  • 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
  • Median absolute prediction error
    • Time Frame: during CPB

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tae Kyong Kim, Clinical Professor – Seoul National University Hospital
  • Overall Official(s)
    • Tae Kyong Kim, MD, Principal Investigator, Seoul National University Hospital

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