Depth of Anesthesia in Cardiac Surgery | NCT01524354 | Trialant

Depth of Anesthesia in Cardiac Surgery | NCT01524354 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Patients received maintenance of anesthesia with continuous infusion of propofol according to recommendations of the manufacturer.	Procedure: maintenance of anesthesia
cerebral state index	Active Comparator	Patients received continuous infusion of propofol with rate maintaining cerebral state index (CSI) between 40 and 60 points.	Procedure: maintenance of anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
maintenance of anesthesia	Procedure	intraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points	cerebral state index

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
duration of postoperative mechanical ventilation	Criteria for termination of postoperative respiratory support were the following: patient able to cooperate; adequate muscular tone; SpO2 > 95% with FiO2 0.5; PaCO2 < 45 mm Hg; postoperative bleeding rate < 50 mL hr-1; stable hemodynamics without inotropic/vasopressor support; body temperature of > 35 °C. Temporary pacing was not regarded as a contraindication for tracheal extubation.	24 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
length of ICU stay	The time until 'fit for ICU discharge' criteria as well as the actual length of the ICU stay were registered. The 'fit for ICU discharge' criteria included the following: fully oriented patient, SaO2 > 90% on room air, no episodes of severe arrhythmias, bleeding < 50 mL hr-1, diuresis > 0.5 mL kg-1 hr-1, no need for inotropic/vasopressor support and no signs of ischemia on ECG.