Romanian Entropy Clinical Study Network

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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General Anesthetic Drug Adverse Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Entropy Group

General Anesthesia using Entropy Monitoring

Monitoring

Intervention Type DEVICE

Monitoring

Control Group

General Anesthesia without Entropy (Control Group)

No interventions assigned to this group

Interventions

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Monitoring

Intervention Type DEVICE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No