Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712528
• Other study ID #: KUH1160080
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2016
• Last updated: December 4, 2017
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2017
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• remifentanil-based

• sevoflurane-sufentanil balanced

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach BIS > 80	Time to reach BIS > 80 after surgery	1 minute
Secondary	Extubation time	Time to perform extubation after surgery	1 minute