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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-Loop propofol Target control infusion | Active Comparator | Closed loop target controlled infusion(TCI) TIVA with propofol using BD TCI pumps guided by entropy and SPI |
|
| Open-loop propofol target control infusion | Active Comparator | Open-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-Loop propofol Target controlled infusion by Entropy and SPI | Device | Closed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of propofol | Total consumption of propofol during surgery | 1 day |
| Number of hypotension events | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Subbaih institute of medical sciences | Recruiting | Shimoga | Karnataka | India |
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Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol
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|
| Open-loop propofol target controlled infusion | Device | Propofol target controlled infusion using Schnider algorithm to determine effect site concentration |
|
|
| ID | Term |
|---|---|
| D058926 | Intraoperative Awareness |
| ID | Term |
|---|---|
| D007431 | Intraoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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