Romanian Entropy Clinical Study Network (ROEntropy)

Romanian Society of Anesthesia and Intensive Care

Status: Unknown

Conditions: General Anesthetic Drug Adverse Reaction

Treatments: Device: Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT03210077

ROE20171

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

500 participants in 2 patient groups

Entropy Group

Description:

General Anesthesia using Entropy Monitoring

Treatment:

Device: Monitoring

Control Group

Description:

General Anesthesia without Entropy (Control Group)