Anesthesia Awareness
Conditions
Keywords
Closed loop, Entropy, Surgical pleth index, Adequacy of Anesthesia, Target controlled infusion
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.
Interventions
DEVICEClosed-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
DEVICEOpen-loop propofol target controlled infusion
Propofol target controlled infusion using Schnider algorithm to determine effect site concentration
Sponsors
KVG Medical College and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Total consumption of propofol | 1 day | Total consumption of propofol during surgery |
| Number of hypotension events | 1 day | — |
Countries
India
Outcome results
None listed