drugset / Trial / NCT02400879

Remifentanil Anesthesia and Postoperative BIS in Cardiac Surgery

NCT02400879

Completed 38 enrolled Konkuk University Medical Center
RandomizedParallel-groupSingle-blindSupportive care

Summary

Background: Although remifentanil based anesthesia has been preferred for fast-track cardiac anesthesia, its recovery profile in cognitive function has not been investigated. Authors determined postoperative Bispectral index (BIS) score as well as extubation time after remifentanil-based propofol-supplemented anesthesia and compared them with those after conventional balanced sevoflurane-sufentanil anesthesia. Methods: Patients undergoing cardiac surgery using moderate hypothermic cardiopulmonary bypass (CPB) will be randomly allocated to get remifentanil-based propofol-supplemented (Group R) or conventional sevoflurane-sufentanil regimen (Group C) in the study period. For anesthetic induction and maintenance, fixed target controlled infusion (TCI) of remifentanil (plasma concentration 20 ng/ml) and TCI-propofol for maintaining BIS score 40-60 (effect concentration 0.8-1.5 μg/ml) in Group R, and TCI-sufentanil (Cp 0.4- 0.8 ng/ml) and sevoflurane inhalation for maintaining 80-120 % of baseline BP and BIS \< 60 (\< 1.5 MAC) in Group C, respectively. Authors will analyze postoperative recovery of cognitive function by using BIS after the use of remifentanil-based propofol-supplemented anesthesia for cardiac surgery and to compare them to those after the use of conventional balanced sevoflurane-sufentanil anesthesia.

Timeline

Start
2015-10
Primary completion
2015-10
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Remifentanil Small molecule 0.7 ug/kg
Comparator Remifentanil Small molecule 0.8 ug/kg
Comparator Sevoflurane Other / unclassified Inhaled
Comparator Sufentanil Other / unclassified 0.4 ng/ml
Comparator Sufentanil Other / unclassified 0.8 ng/ml