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

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ClinicalTrials.gov Identifier: NCT03773588
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Shivakumar M C, MD, KVG Medical College and Hospital

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE October 10, 2018
Estimated Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Total consumption of propofol [ Time Frame: 1 day ]
    Total consumption of propofol during surgery
  • Number of hypotension events [ Time Frame: 1 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion Total Intravenous Anesthesia With Propofol
Official Title  ICMJE Spatial Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion (TCI) Total Intravenous Anaesthesia (TIVA) With Propofol
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Anesthesia Awareness
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Device: Closed-Loop propofol Target controlled infusion 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
    Intervention: Device: Open-loop propofol target controlled infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2019
Estimated Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773588
Other Study ID Numbers  ICMJE SMCH01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shivakumar M C, MD, KVG Medical College and Hospital
Study Sponsor  ICMJE KVG Medical College and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account KVG Medical College and Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP