Who is sponsoring NCT02712528?

NCT02712528 is sponsored by Konkuk University Medical Center.

What condition does NCT02712528 study?

NCT02712528 studies Cardiac Surgery.

What drugs are being tested in NCT02712528?

Interventions: remifentanil-based, sevoflurane-sufentanil balanced.

What is the status of NCT02712528?

NCT02712528 is currently COMPLETED.

Last reviewed 2017-12-04 · How we verify

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

NCT02712528 Phase 4 COMPLETED

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.

Details

Lead sponsor	Konkuk University Medical Center
Phase	Phase 4
Status	COMPLETED
Enrolment	43
Start date	2015-05
Completion	2016-12

Conditions

Cardiac Surgery

Interventions

remifentanil-based
sevoflurane-sufentanil balanced

Primary outcomes

Time to reach BIS > 80 — 1 minute
Time to reach BIS \> 80 after surgery

Countries

South Korea