Modulation of General Anesthesia Using Entropy and Surgical Pleth Index

NCT03095430 | Completed DMC

• 1 other identifier: 20161213CA
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

The critically ill polytrauma patient is one of the most complex cases with regard to the optimization of the intensive care, anesthesia, as well as postoperative management. One of the most important steps in the complex management of such patients is the modulation of anesthesia and the volemic resuscitation, especially in the first hours post-trauma, and in the operating room admission. 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 and SPI it is possible to obtain an appropriate management regarding resuscitation and volume replacement. Furthermore it assumes that an adequate anesthesia, and resuscitation singled volume replacement can reduce morbidity and mortality rates as well as the period of stay in the ICU and recovery time.

Conditions

Trauma; General Anaesthetic Drug Overdose

Keywords

Trauma; General Anesthesia; Surgical Pleth Index; Entropy

Outcome Measures

Primary Outcomes (3)

• Change of systolic blood pressure baseline

  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 from Baseline Systolic Blood Pressure at 1 hour

• Change of heart beat rate baseline

  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)

  Change from Baseline heart beat rate at 1 hour

• Opioid consumption

  Evaluating the opioid consumption by general anesthesia-guided with Entropy and SPI

  Through study completion, an average of 1 year

Study Arms (2)

ESPI Group

General Anesthesia using Entropy and Surgical Pleth Index Monitoring

Device: Monitoring

Control Group

General Anesthesia without Entropy and Surgical Pleth Index (Control Group)

Interventions

Monitoring DEVICE

Monitoring

ESPI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Polytrauma patients admitted in OR

You may qualify if:

• 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;

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
• University of Medicine and Pharmacy "Victor Babes" Timisoara: collaborator

Related Publications (1)

• Rogobete AF, Sandesc D, Cradigati CA, Sarandan M, Papurica M, Popovici SE, Vernic C, Bedreag OH. Implications of Entropy and Surgical Pleth Index-guided general anaesthesia on clinical outcomes in critically ill polytrauma patients. A prospective observational non-randomized single centre study. J Clin Monit Comput. 2018 Aug;32(4):771-778. doi: 10.1007/s10877-017-0059-2. Epub 2017 Aug 30.

  PMID: 28856631 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Alexandru Rogobete, MSc, PhDs, Clin Res

  Romanian Society of Anesthesia and Intensive Care

  PRINCIPAL INVESTIGATOR

• Ovidiu Horea Bedreag, MD, PhD, Asssit Prof

  Victor Babes University of Medicine and Pharmacy Timisoara

  STUDY DIRECTOR

• Dorel Sandesc, MD, PhD, Prof

  Victor Babes University of Medicine and Pharmacy Timisoara

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 29, 2017
• Study Start: January 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: February 1, 2017
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share