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

Cardiopulmonary Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566733
• Other study ID #: Remifentanil_CPB
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2015
• Last updated: October 18, 2016
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthetics
• Anesthetics, Intravenous
• Cardiopulmonary Bypass
• Pharmacology

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median prediction error		during CPB	No
Secondary	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	No
Secondary	Median absolute prediction error		during CPB	No