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

Anesthesia Awareness Clinical Trial

— Closedloop TCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03773588
• Other study ID #: SMCH01
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: December 2018
• Source: KVG Medical College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 15, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Awareness
• Intraoperative Awareness

Intervention

Device:
• Closed-Loop propofol Target controlled infusion by Entropy and SPI
Closed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index
• Open-loop propofol target controlled infusion
Propofol target controlled infusion using Schnider algorithm to determine effect site concentration

Locations

Country	Name	City	State
India	Subbaih institute of medical sciences	Shimoga	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
KVG Medical College and Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time taken for recovery from Anesthesia	Total time taken for recovery after stopping of infusion	1 day
Secondary	Total consumption of propofol	Total consumption of propofol during surgery	1 day
Secondary	Number of hypotension events		1 day