Romanian Entropy Clinical Study Network

• Conditions: General Anesthetic Drug Adverse Reaction
• Interventions: Device: Monitoring

• Registration Number: NCT03210077
• Lead Sponsor: Romanian Society of Anesthesia and Intensive Care

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-06
• Study Start: 2017-09-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Entropy Group	Monitoring	General Anesthesia using Entropy Monitoring

Primary Outcome Measures

Name	Time	Method
Change of systolic blood pressure baseline	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	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)

Trial Locations

Locations (1)

Romanian Society of Anesthesia and Intensive Care; 🇷🇴 Timisoara, Romania