Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery

Phase 4

Completed

• Conditions: Cardiac Surgery
• Interventions: Drug: remifentanil-based; Drug: sevoflurane-sufentanil balanced

• Registration Number: NCT02712528
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

Backgrounds: Monitoring of Bispectral index (BIS) has been regarded as useful to determine the degree of intraoperative hypnosis. Major factors of postoperative recovery after cardiac surgery include patient's recovery in cognitive function from the postoperative residual effects of anesthetics, such as opioids and sedatives, administered during intraoperative period. Therefore employing anesthetic regimens which can provide earlier recovery in cognitive function would be beneficial in facilitating fast-track cardiac surgery with earlier postoperative extubation and discharge from the intensive care unit (ICU).

Previous investigations suggested efficacy of BIS in evaluating the degree of postoperative hypnosis in the ICU.

The present study compares the time for reaching BIS greater than 80 after using 2 different anesthesia regimens for cardiac surgery, remifentanil-based regimen and sevoflurane-sufentanil balanced regimen.

Analyzing the changes immediately after cardiac surgery would be useful to determine the degree of patient's postoperative emergence.

Materials and Methods:

During study period, patients undergoing elective cardiac surgery in Konkuk University Medical Center are randomly assigned to get remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60 (Group R) or sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) balanced regimen in Group S.

All patients get intravenous patient controlled anesthesia consisting of alfentanyl and ondansetron after surgery. Supplemental remifentanil 0.25-0.3 mcg/kg/min is administered during postoperative 2 hours in Group R.

As a primary objective, inter-group difference in the time for achieving BIS greater than 80 is determined.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-18
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• patients undergoing elective coronary artery bypass surgery

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Exclusion Criteria

• combined valve surgery
• preoperative intraaortic balloon pumping
• preoperative low cardiac output syndrome
• chronic obstructive pulmonary disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remifentanil-based	remifentanil-based	remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60
sevoflurane-sufentanil balanced	sevoflurane-sufentanil balanced	balanced sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) regimen

Primary Outcome Measures

Name	Time	Method
Time to reach BIS > 80	1 minute	Time to reach BIS \> 80 after surgery

Secondary Outcome Measures

Name	Time	Method
Extubation time	1 minute	Time to perform extubation after surgery

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of