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

Not Applicable

• Conditions: Anesthesia Awareness
• Interventions: Device: Closed-Loop propofol Target controlled infusion by Entropy and SPI; Device: Open-loop propofol target controlled infusion

• Registration Number: NCT03773588
• Lead Sponsor: KVG Medical College and Hospital

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.

Study Timeline

• Study Start: 2018-10-10
• Status Verified: 2018-12
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-11
• Last Update Submitted: 2018-12-11
• Study First Posted: 2018-12-12
• Last Update Posted: 2018-12-12
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Closed-Loop propofol Target control infusion	Closed-Loop propofol Target controlled infusion by Entropy and SPI	Closed loop target controlled infusion(TCI) TIVA with propofol using BD TCI pumps guided by entropy and SPI
Open-loop propofol target control infusion	Open-loop propofol target controlled infusion	Open-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm

Primary Outcome Measures

Name	Time	Method
Adequacy of anesthesia	1 day	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.
Time taken for recovery from Anesthesia	1 day	Total time taken for recovery after stopping of infusion

Secondary Outcome Measures

Name	Time	Method
Number of hypotension events	1 day
Total consumption of propofol	1 day	Total consumption of propofol during surgery

Trial Locations

Locations (1)

Subbaih institute of medical sciences; 🇮🇳 Shimoga, Karnataka, India