Romanian Entropy Clinical Study Network

NCT03210077 | Unknown DMC

• 1 other identifier: ROE20171
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthetic Drug Adverse Reaction

Keywords

general anesthesia; Entropy; Hypnosis

Outcome Measures

Primary Outcomes (2)

• 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).

  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)

  Change from Baseline heart rate at 10 minutes

Study Arms (2)

Entropy Group

General Anesthesia using Entropy Monitoring

Device: Monitoring

Control Group

General Anesthesia without Entropy (Control Group)

Interventions

Monitoring DEVICE

Monitoring

Entropy Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Romanian Society of Anesthesia and Intensive Care: lead

Study Sites (1)

Romanian Society of Anesthesia and Intensive Care

Timișoara, Romania

Location

Study Officials

• Alexandru Florin Rogobete, PhDs

  Romanian Society of Anesthesia and Intensive Care

  PRINCIPAL INVESTIGATOR

• Dorel Sandesc, Prof

  Romanian Society of Anesthesia and Intensive Care

  STUDY CHAIR

• Ovidiu Bedreag, Assoc Prof

  Romanian Society of Anesthesia and Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PhDs, Clinical Researcher

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 6, 2017
• Study Start: September 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 30, 2020
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)