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

Phase 4

Completed

• Conditions: Anesthetics, Intravenous; Pharmacology; Anesthetics; Cardiopulmonary Bypass
• Interventions: Drug: Remiva; Drug: Ultiva

• Registration Number: NCT02566733
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-29
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remiva	Remiva	This experimental group will use a generic drug of remifentanil, Remiva™ from Hana Pharmaceutical company.
Ultiva	Ultiva	This arm group will use a brand-named drug of remifentanil, Ultiva™ from GlaxoSmithKline company.

Primary Outcome Measures

Name	Time	Method
Median prediction error	during CPB

Secondary Outcome Measures

Name	Time	Method
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
Median absolute prediction error	during CPB

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of