General Anesthetic Drug Adverse ReactionROEntropyNCT03210077
Romanian Entropy Clinical Study Network
An observational study of General Anesthetic Drug Adverse Reaction, run by Romanian Society of Anesthesia and Intensive Care at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- General Anesthetic Drug Adverse Reaction
- What is being tested?
- Monitoring
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteRomania
- Study dates
- 1 Sep 2017to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who needs general anesthesia and meet the inclusion criteria.
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- General Anesthetic Drug Adverse Reaction
- Being tested
- Monitoring
- Keywords
- general anesthesia, Entropy, Hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonitoringDevice
Monitoring
| Study group | Role | What they receive |
|---|---|---|
| Entropy Group | General Anesthesia using Entropy Monitoring Receives: Device: Monitoring | |
| Control Group | General Anesthesia without Entropy (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline Systolic Blood Pressure at 10 minutes
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)
Measured: Change from Baseline heart rate at 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthetic Drug Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Romanian Society of Anesthesia and Intensive Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care
- Investigators
- Alexandru Florin Rogobete, PhDs, Principal investigator, Romanian Society of Anesthesia and Intensive CareDorel Sandesc, Prof, Study chair, Romanian Society of Anesthesia and Intensive CareOvidiu Bedreag, Assoc Prof, Study director, Romanian Society of Anesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210077
- Sponsor's protocol ID
- ROE20171
- Acronym
- ROEntropy
- Status last verified
- Mar 2019
- First submitted
- 4 Jul 2017
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Romanian Entropy Clinical Study Network
- ClinicalTrials.gov ID
- NCT03210077
- Acronym / sponsor ID
- ROEntropy / ROE20171
- Conditions
- General Anesthetic Drug Adverse Reaction
- Keywords
- general anesthesia, Entropy, Hypnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Romanian Society of Anesthesia and Intensive CareUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entropy Group | – | Device: MonitoringGeneral Anesthesia using Entropy Monitoring |
| Control Group | – | –General Anesthesia without Entropy (Control Group) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who needs general anesthesia and meet the inclusion criteria.
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonitoringMonitoring | Device | Entropy Group |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No
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Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthetic Drug Adverse Reaction, run by Romanian Society of Anesthesia and Intensive Care at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of systolic blood pressure baseline (time frame: Change from Baseline Systolic Blood Pressure at 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.