Romanian Entropy Clinical Study Network

Study Overview
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Brief Summary
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The critically ill patient is one of the most complex cases with regard to the optimization of the anesthesia, as well as postoperative management. One of the most important steps in the complex management of such patients is the modulation of anesthesia for every patient needs. We start with the assumptions that the optimization of anesthesia should depend on each patient, being conducted in an individual manner. We also believe that by individualizing the anesthesia by monitoring the entropy it is possible to obtain an appropriate management regarding hemodynamic complications during anesthesia including tachycardia, bradycardia, hypotension and hypertension.

Official Title
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Romanian Entropy Clinical Study Network

Conditions
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General Anesthetic Drug Adverse Reaction

Intervention / Treatment
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* Device: Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I, II, III; written consent accepted to be enrolled in the study; in polytrauma patients in the operation theatre who are brought directly through the emergency department, written consent is obtained from the relatives, in accordance to the national law number 206, of 2004, for a good and correct scientific research, in the situation where the patient is no capable to sign or give the written consent; Exclusion Criteria: cardiac pacemaker; atrial fibrillation at the time of presentation in the operation theatre; any subject with epidural catheter, placed pre-operatively; allergy to Propofol or another anesthetic drugs; pregnancy; presence of neuromuscular disease; presence of neurologic disease;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Entropy Group<br>General Anesthesia using Entropy Monitoring | Device: Monitoring<br>* Monitoring<br>|
| Control Group<br>General Anesthesia without Entropy (Control Group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of systolic blood pressure baseline | Evaluating the impact of general anesthesia guided with Entropy on the hemodynamic instability in the critically ill patient; hemodynamic instability is represented and characterized by high blood pressure episodes (hypertension), or low blood pressure (hypotension). | Change from Baseline Systolic Blood Pressure at 10 minutes | 
| Change of heart beat rate baseline | Evaluating the impact of general anesthesia guided with Entropy on the heart rate in the critically ill polytrauma patient; cardiac rate instability is represented and characterized by high cardiac rate (tachycardia), or low cardiac rate (bradycardia) | Change from Baseline heart rate at 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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general anesthesia, Entropy, Hypnosis