ClinicalTrials.gg
Status unknownNCT03210077ROEntropyUpdated Mar 6, 2019

Romanian Entropy Clinical Study Network

An observational study in General Anesthetic Drug Adverse Reaction, sponsored by Romanian Society of Anesthesia and Intensive Care. Status unknown at 1 site in Romania. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-06.

Sponsored by Romanian Society of Anesthesia and Intensive Care · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • General Anesthetic Drug Adverse Reaction

Keywords

  • general anesthesia
  • Entropy
  • Hypnosis
03

In context

Lead sponsor

Romanian Society of Anesthesia and Intensive Care is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients who needs general anesthesia and meet the inclusion criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Entropy Group

    General Anesthesia using Entropy Monitoring

    Device: Monitoring

  • Control Group

    General Anesthesia without Entropy (Control Group)

Interventions

  • DeviceMonitoring

    Monitoring

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Change from Baseline Systolic Blood Pressure at 10 minutes

  2. 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)

    Time frame: Change from Baseline heart rate at 10 minutes

07

Study locations

1 site
  • Romanian Society of Anesthesia and Intensive Care
    Timișoara, Romania
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2017 (actual). Primary completion is estimated for Dec 2019, 27 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 4, 2017
First posted
Jul 6, 2017
StartActual
Sep 1, 2017
Primary completionEst.
Dec 31, 2019
CompletionEst.
Mar 30, 2020
Last update
Mar 6, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03210077
Lead sponsor
Romanian Society of Anesthesia and Intensive Care
Responsible party
Alexandru Florin Rogobete (MSc, PhDs, Clinical Researcher, Romanian Society of Anesthesia and Intensive Care) — Principal investigator
First posted
Jul 6, 2017
Start date
Sep 1, 2017
Primary completion
Dec 31, 2019 (estimated)
Completion
Mar 30, 2020 (estimated)
Last update
Mar 6, 2019

Study contacts

Alexandru Florin Rogobete, PhDs
principal investigator · Romanian Society of Anesthesia and Intensive Care
Dorel Sandesc, Prof
study chair · Romanian Society of Anesthesia and Intensive Care
Ovidiu Bedreag, Assoc Prof
study director · Romanian Society of Anesthesia and Intensive Care

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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