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

Primary Purpose

Anesthesia Awareness

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Closed-Loop propofol Target controlled infusion by Entropy and SPI
Open-loop propofol target controlled infusion
Sponsored by
KVG Medical College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia Awareness focused on measuring Closed loop, Entropy, Surgical pleth index, Adequacy of Anesthesia, Target controlled infusion

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Subbaih institute of medical sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Closed-Loop propofol Target control infusion

Open-loop propofol target control infusion

Arm Description

Closed loop target controlled infusion(TCI) TIVA with propofol using BD TCI pumps guided by entropy and SPI

Open-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm

Outcomes

Primary Outcome Measures

Adequacy of anesthesia
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
Total time taken for recovery after stopping of infusion

Secondary Outcome Measures

Total consumption of propofol
Total consumption of propofol during surgery
Number of hypotension events

Full Information

First Posted
December 10, 2018
Last Updated
December 11, 2018
Sponsor
KVG Medical College and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03773588
Brief Title
Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion Total Intravenous Anesthesia With Propofol
Acronym
Closedloop TCI
Official Title
Spatial Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion (TCI) Total Intravenous Anaesthesia (TIVA) With Propofol
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Anticipated)
Study Completion Date
January 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KVG Medical College and Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Awareness
Keywords
Closed loop, Entropy, Surgical pleth index, Adequacy of Anesthesia, Target controlled infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Closed-Loop propofol Target control infusion
Arm Type
Active Comparator
Arm Description
Closed loop target controlled infusion(TCI) TIVA with propofol using BD TCI pumps guided by entropy and SPI
Arm Title
Open-loop propofol target control infusion
Arm Type
Active Comparator
Arm Description
Open-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm
Intervention Type
Device
Intervention Name(s)
Closed-Loop propofol Target controlled infusion by Entropy and SPI
Other Intervention Name(s)
Closed-loop propofol Target controlled infusion
Intervention Description
Closed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index
Intervention Type
Device
Intervention Name(s)
Open-loop propofol target controlled infusion
Other Intervention Name(s)
Open-loop propofol TCI
Intervention Description
Propofol target controlled infusion using Schnider algorithm to determine effect site concentration
Primary Outcome Measure Information:
Title
Adequacy of anesthesia
Description
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 Frame
1 day
Title
Time taken for recovery from Anesthesia
Description
Total time taken for recovery after stopping of infusion
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Total consumption of propofol
Description
Total consumption of propofol during surgery
Time Frame
1 day
Title
Number of hypotension events
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Subbaih institute of medical sciences
City
Shimoga
State/Province
Karnataka
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivakumar M Channabasappa, MD
Phone
9620306582
Email
drshivakumar.m.c@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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