Depth of Anesthesia in Cardiac Surgery

Not Applicable

Completed

• Conditions: Heart Valve Diseases
• Interventions: Procedure: maintenance of anesthesia

• Registration Number: NCT01524354
• Lead Sponsor: Northern State Medical University

Brief Summary

The aim of our study was to evaluate the significance of monitoring anesthetic depth for the conduct of anesthesia and the early postoperative period in patients subjected to surgical correction of combined valvular disorders.

Detailed Description

Our aim was to evaluate the effect of monitoring anesthetic depth on duration of postoperative mechanical ventilation and ICU stay after surgical correction of combined valvular disorders.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-11
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• requirement of surgical correction of two or more valves

Exclusion Criteria

• no

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	maintenance of anesthesia	Patients received maintenance of anesthesia with continuous infusion of propofol according to recommendations of the manufacturer.
cerebral state index	maintenance of anesthesia	Patients received continuous infusion of propofol with rate maintaining cerebral state index (CSI) between 40 and 60 points.

Primary Outcome Measures

Name	Time	Method
duration of postoperative mechanical ventilation	24 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
length of ICU stay	7 days postoperatively	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.