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Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02712528
Enrollment
43
Registered
2016-03-18
Start date
2015-05-31
Completion date
2016-12-31
Last updated
2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

bispectral index, extubation, recovery, remifentanil

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.

Interventions

DRUGremifentanil-based
DRUGsevoflurane-sufentanil balanced

Sponsors

Konkuk University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to reach BIS > 801 minuteTime to reach BIS \> 80 after surgery

Secondary

MeasureTime frameDescription
Extubation time1 minuteTime to perform extubation after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026