Depth of Anesthesia in Cardiac Surgery

Study Overview
=================
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.

Official Title
-----------------
Monitoring of Anesthetic Depth During Surgical Correction of Acquired Valvular Disorders

Conditions
-----------------
Heart Valve Diseases

Intervention / Treatment
-----------------
* Procedure: maintenance of anesthesia
* Procedure: maintenance of anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: requirement of surgical correction of two or more valves Exclusion Criteria: no

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients received maintenance of anesthesia with continuous infusion of propofol according to recommendations of the manufacturer. | Procedure: maintenance of anesthesia<br>* intraoperative maintenance of anesthesia with propofol according to recommendations of the manufacturer<br>* Other names: Controlled anesthesia depth;|
| Active Comparator: cerebral state index<br>Patients received continuous infusion of propofol with rate maintaining cerebral state index (CSI) between 40 and 60 points. | Procedure: maintenance of anesthesia<br>* intraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points<br>* Other names: Controlled anesthesia depth;|

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

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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. | 7 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depth of anesthesia, valve surgery