Departamentul de educaţie medicală şi cercetare

Acest department are ca scop susţinerea educaţiei medicale continue în domeniul anesteziei şi terapiei intensive şi îşi propune de asemenea să susţină şi să coordoneze proiecte de cercetare la nivel naţional şi internaţional.

Romanian Entropy Clinical Study Network (ROEntropy)

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.

Condition Intervention
General Anesthetic Drug Adverse Reaction Device: Monitoring

 

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Romanian Entropy Clinical Study Network 

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).

 

 

Estimated Enrollment: 500
Anticipated Study Start Date: September 1, 2017
Estimated Study Completion Date: March 30, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)

 

Groups/Cohorts Assigned Interventions
Entropy Group
General Anesthesia using Entropy Monitoring
Device: Monitoring
Monitoring
Control Group
General Anesthesia without Entropy (Control Group)
 

 

Eligibility

Ages Eligible for Study: Child, Adult, Senior
Sexes Eligible for Study:  All
Accepts Healthy Volunteers: No 
Sampling Method: Probability Sample

 

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

Principal Investigator: Alexandru Florin Rogobete, PhDs Romanian Society of Anesthesia and Intensive Care
Study Chair: Dorel Sandesc, Prof Romanian Society of Anesthesia and Intensive Care
Study Director: Ovidiu Bedreag, Assoc Prof Romanian Society of Anesthesia and Intensive Care

More Information

Responsible Party: Alexandru Florin Rogobete, MSc, PhDs, Clinical Researcher, Romanian Society of Anesthesia and Intensive Care
ClinicalTrials.gov Identifier: NCT03210077 History of Changes
Other Study ID Numbers:  ROE20171
Study First Received:  July 4, 2017
Last Updated:  July 4, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:  No

 

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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Call for centres form - President Office Approval