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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02566733
Enrollment
56
Registered
2015-10-02
Start date
2015-10-31
Completion date
2016-06-30
Last updated
2016-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetics, Anesthetics, Intravenous, Cardiopulmonary Bypass, Pharmacology

Keywords

remifentanil

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.

Interventions

DRUGRemiva

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

DRUGUltiva

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Median prediction errorduring CPB

Secondary

MeasureTime frame
changes of measured total remifentanil concentration1 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 errorduring CPB

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026