Clinical trial NCT03773588: Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion Total Intravenous Anesthesia With Propofol
Official title: Spatial Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion (TCI) Total Intravenous Anaesthesia (TIVA) With Propofol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia Awareness
Keywords: Closed loop
Entropy
Surgical pleth index
Adequacy of Anesthesia
Target controlled infusion
Lead sponsor: KVG Medical College and Hospital
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adequacy of anesthesia
timeFrame: 1 day
measure: Time taken for recovery from Anesthesia
timeFrame: 1 day
Secondary outcomes:
measure: Total consumption of propofol
timeFrame: 1 day
measure: Number of hypotension events
timeFrame: 1 day
Other outcomes:
Locations:
city: Shimoga
country: India
facility: Subbaih institute of medical sciences
state: Karnataka
Study officials:
References: