An interventional study of Closed-Loop propofol Target controlled infusion by Entropy and SPI and Open-loop propofol target controlled infusion in Anesthesia Awareness, sponsored by KVG Medical College and Hospital. Status unknown at 1 site in India. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by KVG Medical College and Hospital · Not applicable, Interventional, and Treatment
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.
51 studies on the registry are indexed under Intraoperative Awareness; 7 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 25 interventional studies indexed under Intraoperative Awareness.
Browse Intraoperative Awareness studies →KVG Medical College and Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm
Device: Open-loop propofol target controlled infusion
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
Propofol target controlled infusion using Schnider algorithm to determine effect site concentration
Also known as: Open-loop propofol TCI
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.
Time frame: 1 day
Time taken for recovery from Anesthesia
Total time taken for recovery after stopping of infusion
Time frame: 1 day
Total consumption of propofol
Total consumption of propofol during surgery
Time frame: 1 day
Number of hypotension events
Time frame: 1 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
KVG Medical College and Hospital