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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03773588
Study type Interventional
Source KVG Medical College and Hospital
Contact
Status Recruiting
Phase N/A
Start date October 10, 2018
Completion date January 15, 2019

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