Modulation of General Anesthesia Using Entropy and Surgical Pleth Index (ESPTR)

Study Official Title

Modulation of General Anesthesia Using Entropy and Surgical Pleth Index (ESPTR)

ClinicalTrials.Gov Full Text View: https://clinicaltrials.gov/ct2/show/NCT03095430?term=Rogobete&rank=1

Study Type:	Observational
Study Design:	Observational Model: Case-Control Time Perspective: Prospective

This study has been completed.

Sponsor: Romanian Society of Anesthesia and Intensive Care 

Collaborator: University of Medicine and Pharmacy "Victor Babes" Timisoara

Information provided by (Responsible Party): Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care

ClinicalTrials.gov Identifier: NCT03095430

Groups/Cohorts	Assigned Interventions
ESPI Group General Anesthesia using Entropy and Surgical Pleth Index Monitoring	Device: Monitoring Monitoring
Control Group General Anesthesia without Entropy and Surgical Pleth Index (Control Group)

 

Principal Investigator:	Alexandru Rogobete, MSc, PhDs, Clin Res	Romanian Society of Anesthesia and Intensive Care
Study Director:	Ovidiu Horea Bedreag, MD, PhD, Asssit Prof	Victor Babes University of Medicine and Pharmacy Timisoara
Study Chair:	Dorel Sandesc, MD, PhD, Prof	Victor Babes University of Medicine and Pharmacy Timisoara

 

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

 

 

 

Keywords provided by Romanian Society of Anesthesia and Intensive Care: Trauma, General Anesthesia, Surgical Pleth Index, Entropy.

Additional relevant MeSH terms:

Drug Overdose Substance-Related Disorders Chemically-Induced Disorders

Anesthetics Central Nervous System Depressants Physiological Effects of Drugs

 

 

 

 

ClinicalTrials.gov processed this record on April 28, 2017

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Sampling Method:	Probability Sample

 

 

 

 

 

Study Population
Polytrauma patients admitted in OR

Criteria
Inclusion Criteria:

• age limit: between 18 years to 80 years;
• gender: male and female;
• within 2 hours of surgical intervention;
• 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;

Further study details as provided by Romanian Society of Anesthesia and Intensive Care:

Primary Outcome Measures:

• Change of systolic blood pressure baseline [Time Frame: Change from Baseline Systolic Blood Pressure at 1 hour]
  Evaluating the impact of general anesthesia guided with Entropy and SPI on the hemodynamic instability in the critically ill polytrauma 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 beat rate at 1 hour]
  Evaluating the impact of general anesthesia guided with Entropy and SPI 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)
• Opioid consumption [Time Frame: Through study completion, an average of 1 year]
  Evaluating the opioid consumption by general anesthesia-guided with Entropy and SPI