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

Study Overview
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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.

Official Title
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Spatial Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion (TCI) Total Intravenous Anaesthesia (TIVA) With Propofol

Conditions
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Anesthesia Awareness

Intervention / Treatment
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* Device: Closed-Loop propofol Target controlled infusion by Entropy and SPI
* Device: Open-loop propofol target controlled infusion


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Closed-Loop propofol Target control infusion<br>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<br>* Closed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index<br>* Other names: Closed-loop propofol Target controlled infusion;|
| Active Comparator: Open-loop propofol target control infusion<br>Open-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm | Device: Open-loop propofol target controlled infusion<br>* Propofol target controlled infusion using Schnider algorithm to determine effect site concentration<br>* Other names: Open-loop propofol TCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 
| Time taken for recovery from Anesthesia | Total time taken for recovery after stopping of infusion | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption of propofol | Total consumption of propofol during surgery | 1 day | 
| Number of hypotension events |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closed loop, Entropy, Surgical pleth index, Adequacy of Anesthesia, Target controlled infusion