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Completed

NCT Number: NCT02566733

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.

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Key information

Conditions

Anesthetics, Intravenous Anesthetics Cardiopulmonary Bypass Pharmacology

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remiva

Drug

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

Other names: generic drug of remifentanil, Remiva™

Ultiva

Drug

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

Other names: brand-named drug of remifentanil, Ultiva™

Primary outcomes

  1. Median prediction error

    Time frame: during CPB

Secondary outcomes

  1. 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

  2. Median absolute prediction error

    Time frame: during CPB

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2015
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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