Purpose

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.

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Further study details as provided by Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care:

Primary Outcome Measures:

• Change of systolic blood pressure baseline [Time Frame: Change from Baseline Systolic Blood Pressure at 10 minutes].
  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 of heart beat rate baseline [Time Frame: Change from Baseline heart rate at 10 minutes].
  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).

Eligibility

Study Population

All patients who needs general anesthesia and meet the inclusion criteria.

Criteria

Inclusion Criteria: age limit: between 18 years to 80 years; gender: male and female; within 2 hours of surgical intervention; 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;

Locations

Romania: Romanian Society of Anesthesia and Intensive Care, Timisoara, Romania

Sponsors and Collaborators

Romanian Society of Anesthesia and Intensive Care

Investigators

More Information

Keywords provided by Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care: general anesthesia, Entropy, Hypnosis.

Additional relevant MeSH terms: Drug-Related Side Effects and Adverse Reactions, Chemically-Induced Disorders.

Downloads

SRATI CLINICAL TRIAL NETWORK – President Office Approval

ROEntropy – SRATI CTN – President Office Approval

Call for centres form

Call for centres form – President Office Approval