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

NCT ID: NCT03773588

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2019-01-15

Brief Summary

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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

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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.

Conditions

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Anesthesia Awareness

Keywords

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Closed loop Entropy Surgical pleth index Adequacy of Anesthesia Target controlled infusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Closed-Loop propofol Target control infusion

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

Group Type ACTIVE_COMPARATOR

Closed-Loop propofol Target controlled infusion by Entropy and SPI

Intervention Type DEVICE

Closed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index

Open-loop propofol target control infusion

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

Group Type ACTIVE_COMPARATOR

Open-loop propofol target controlled infusion

Intervention Type DEVICE

Propofol target controlled infusion using Schnider algorithm to determine effect site concentration

Interventions

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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

Intervention Type DEVICE

Open-loop propofol target controlled infusion

Propofol target controlled infusion using Schnider algorithm to determine effect site concentration

Intervention Type DEVICE

Other Intervention Names

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Closed-loop propofol Target controlled infusion Open-loop propofol TCI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KVG Medical College and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shivakumar M C, MD

Professor and HEAD, Department of Anesthesiologist and critical care medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Subbaih institute of medical sciences

Shimoga, Karnataka, India

Site Status RECRUITING

Countries

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India

Facility Contacts

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Shivakumar M Channabasappa, MD

Role: primary

Other Identifiers

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SMCH01

Identifier Type: -

Identifier Source: org_study_id