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Romanian Entropy Clinical Study Network

Romanian Entropy Clinical Study Network

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03210077
Acronym
ROEntropy
Enrollment
500
Registered
2017-07-06
Start date
2017-09-01
Completion date
2020-03-30
Last updated
2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthetic Drug Adverse Reaction

Keywords

general anesthesia, Entropy, Hypnosis

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.

Interventions

DEVICEMonitoring

Monitoring

Sponsors

Romanian Society of Anesthesia and Intensive Care
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Change of systolic blood pressure baselineChange from Baseline Systolic Blood Pressure at 10 minutesEvaluating 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 baselineChange from Baseline heart rate at 10 minutesEvaluating 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)

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026