Romanian Entropy Clinical Study Network

General Anesthetic Drug Adverse Reaction Clinical Trial

— ROEntropy  

Official title:

Romanian Entropy Clinical Study Network

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03210077
• Other study ID #: ROE20171
• Status: Active, not recruiting
• Start date: September 1, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: March 2019
• Source: Romanian Society of Anesthesia and Intensive Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• General Anesthetic Drug Adverse Reaction

Intervention

Device:
• Monitoring
Monitoring

Locations

Country	Name	City	State
Romania	Romanian Society of Anesthesia and Intensive Care	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
Romanian Society of Anesthesia and Intensive Care

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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