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Clinical Trials/NCT02712528
NCT02712528
Completed
Phase 4

Recovery Profiles of Remifentanil-based vs. Sevoflurane-sufentanil Combined Regimen for Cardiac Surgery

Konkuk University Medical Center1 site in 1 country43 target enrollmentMay 2015

Overview

Phase
Phase 4
Intervention
remifentanil-based
Conditions
Cardiac Surgery
Sponsor
Konkuk University Medical Center
Enrollment
43
Locations
1
Primary Endpoint
Time to reach BIS > 80
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Konkuk University Medical Center

Eligibility Criteria

Inclusion Criteria

  • patients undergoing elective coronary artery bypass surgery

Exclusion Criteria

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

Arms & Interventions

remifentanil-based

remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60

Intervention: remifentanil-based

sevoflurane-sufentanil balanced

balanced sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) regimen

Intervention: sevoflurane-sufentanil balanced

Outcomes

Primary Outcomes

Time to reach BIS > 80

Time Frame: 1 minute

Time to reach BIS \> 80 after surgery

Secondary Outcomes

  • Extubation time(1 minute)

Study Sites (1)

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