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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03773588
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Information provided by (Responsible Party):
Shivakumar M C, MD, KVG Medical College and Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Awareness Device: Closed-Loop propofol Target controlled infusion by Entropy and SPI Device: Open-loop propofol target controlled infusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Spatial Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion (TCI) Total Intravenous Anaesthesia (TIVA) With Propofol
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : January 10, 2019
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
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
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
Other Name: Closed-loop propofol Target controlled infusion

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
Device: Open-loop propofol target controlled infusion
Propofol target controlled infusion using Schnider algorithm to determine effect site concentration
Other Name: Open-loop propofol TCI

Primary Outcome Measures :
  1. 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.

  2. Time taken for recovery from Anesthesia [ Time Frame: 1 day ]
    Total time taken for recovery after stopping of infusion

Secondary Outcome Measures :
  1. Total consumption of propofol [ Time Frame: 1 day ]
    Total consumption of propofol during surgery

  2. Number of hypotension events [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03773588

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Subbaih institute of medical sciences Recruiting
Shimoga, Karnataka, India
Contact: Shivakumar M Channabasappa, MD    9620306582   
Sponsors and Collaborators
KVG Medical College and Hospital
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Responsible Party: Shivakumar M C, MD, Professor and HEAD, Department of Anesthesiologist and critical care medicine, KVG Medical College and Hospital Identifier: NCT03773588    
Other Study ID Numbers: SMCH01
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shivakumar M C, MD, KVG Medical College and Hospital:
Closed loop
Surgical pleth index
Adequacy of Anesthesia
Target controlled infusion
Additional relevant MeSH terms:
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Intraoperative Awareness
Intraoperative Complications
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General