Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery

Study 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.

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

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: remifentanil-based
* Drug: sevoflurane-sufentanil balanced


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: remifentanil-based<br>remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60 | Drug: remifentanil-based<br> <br> |
| Placebo Comparator: sevoflurane-sufentanil balanced<br>balanced sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) regimen | Drug: sevoflurane-sufentanil balanced<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach BIS > 80 | Time to reach BIS > 80 after surgery | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation time | Time to perform extubation after surgery | 1 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bispectral index, extubation, recovery, remifentanil