Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion Total Intravenous Anesthesia With Propofol

Overview

Closed-loop infusion system for target controlled infusion of propofol by using TCI pump designed by BD Technology. (Germany) guided with entropy and surgical pleth index (GE) will not only prevent awareness from Anesthesia but also optimise the dose anesthetic agents based on feedback from adequacy of Anesthesia monitoring. Which not only reduces Anesthesia agents but also enhances recovery from Anesthesia. Innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of Entropy.In this study we performed a randomized, controlled, study to compare closed-loop control and open-loop control of propofol by using the Entropy and SPI guided closed-loop infusion system.

Full Title of Study: “Spatial Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion (TCI) Total Intravenous Anaesthesia (TIVA) With Propofol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 10, 2019

Detailed Description

Monitoring of Adequacy of Anesthesia using Entropy and Surgical pleth index to guide total intravenous anesthesia is more effective to maintain depth of anesthesia compared with target controlled infusion with open systems, it is unclear what driver and variables to achieve this goal be more physiological; in the literature doesn´t exist studies showing that the closed-loop system for hypnotic is better than the controlled algorithm based pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain anesthetic depth. Thus, a system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based on neuromonitoring with Entropy and surgical pleth index as adequacy of Anesthesia depth.

The purpose of this study is to determine the therapeutic effectiveness of a closed loop TCI for administration of intravenous anesthesia using adequacy of anesthesia monitoring to maintain a depth of anesthesia compared to an open loop system TCI.

Interventions

  • Device: Closed-Loop propofol Target controlled infusion by Entropy and SPI
    • Closed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index
  • Device: Open-loop propofol target controlled infusion
    • Propofol target controlled infusion using Schnider algorithm to determine effect site concentration

Arms, Groups and Cohorts

  • Active Comparator: Closed-Loop propofol Target control infusion
    • Closed loop target controlled infusion(TCI) TIVA with propofol using BD TCI pumps guided by entropy and SPI
  • Active Comparator: Open-loop propofol target control infusion
    • Open-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm

Clinical Trial Outcome Measures

Primary Measures

  • Adequacy of anesthesia
    • Time Frame: 1 day
    • Difference in therapeutic effectiveness determined by the time in state suitable anesthetic depth. The proper anesthetic depth is defined as the efficacy to maintain a Spatial entropy in the range of 40 – 60 during a surgery.
  • Time taken for recovery from Anesthesia
    • Time Frame: 1 day
    • Total time taken for recovery after stopping of infusion

Secondary Measures

  • Total consumption of propofol
    • Time Frame: 1 day
    • Total consumption of propofol during surgery
  • Number of hypotension events
    • Time Frame: 1 day

Participating in This Clinical Trial

Inclusion Criteria

  • Older than 18 years
  • Scheduled for noncardiac surgery elective low-risk or intermediate risk. —Expected surgery time greater than 1 hour
  • Procedure requiring general anesthesia
  • Classification of the American Society of Anesthesiologists (ASA) as I,II, lll

Exclusion Criteria

  • Pregnant women
  • Surgery scheduled urgent or emergency
  • Personal history of allergy to eggs or any other part of propofol
  • Personal history of abnormalities or congenital or acquired cognitive sequels: infantile cerebral palsy, Down syndrome, cerebral ischemic disease, traumatic brain injury, brain tumor, autism.
  • Chronic use of benzodiazepines or antipsychotics
  • A patient who does not consent to participate in the study prior to surgery or before randomization
  • Need for anesthetic or analgesic blockade before surgery peripheral nerve

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • KVG Medical College and Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shivakumar M C, MD, Professor and HEAD, Department of Anesthesiologist and critical care medicine – KVG Medical College and Hospital

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