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

NCT03773588 | Unknown DMC

• 1 other identifier: SMCH01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Awareness

Keywords

Closed loop; Entropy; Surgical pleth index; Adequacy of Anesthesia; Target controlled infusion

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Total consumption of propofol

  1 day

• Number of hypotension events

  1 day

Study Arms (2)

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

Device: Closed-Loop propofol Target controlled infusion 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

Device: Open-loop propofol target controlled infusion

Interventions

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

Also known as: Closed-loop propofol Target controlled infusion

Closed-Loop propofol Target control infusion

Open-loop propofol target controlled infusion DEVICE

Propofol target controlled infusion using Schnider algorithm to determine effect site concentration

Also known as: Open-loop propofol TCI

Open-loop propofol target control infusion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KVG Medical College and Hospital: lead

Study Sites (1)

Subbaih institute of medical sciences

Shimoga, Karnataka, India

RECRUITING

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and HEAD, Department of Anesthesiologist and critical care medicine

Model Details: Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 12, 2018
• Study Start: October 10, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 15, 2019
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

IN (1)