Comparison of TIVA by Closed Loop Anaesthesia Delivery System Versus Target Controlled Infusion Device
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Total intravenous anaesthesia (TIVA) is now being adopted as a preferred technique for
providing GA because of its various inherent advantages like reduced PONV incidence, improved
quality of recovery post GA, anti-inflammatory and anti-oxidant action, anti-neoplastic
activity, analgesic action, and absence of greenhouse effect. Over the years propofol-TIVA
delivery has become more methodical due to the use of target-controlled infusion (TCI)
systems. The current TCI technology has evolved with the introduction of the 'open' TCI
concept wherein syringes of any configuration can be attached to the TCI-pumps having
pre-programmed propofol PK-PD models. The two most commonly use propofol PK-PD models are the
Marsh and Schneider models targeting the propofol blood plasma concentration and effect site
concentration in the brain respectively. Automated delivery of propofol using
computer-controlled closed loop anaesthesia device delivers propofol based on patient's
frontal cortex electrical activity as determined by bispectral index (BIS). Evaluation of
anaesthesia delivery by these systems has shown that they deliver propofol and maintain depth
of anaesthesia with far more precision as compared to manual administration. A recent advance
in propofol delivery has been the development of automated closed loop anaesthesia delivery
system. These devices deliver propofol based on patient's frontal cortex electrical activity
as determined by bispectral index (BIS).Closed loop anaesthesia delivery system (CLADS) is an
indigenously developed continuous automated intravenous infusion system which delivers
propofol based on patients' EEG profile (BIS) feedback. Currently there is no data available
comparing the efficacy of TCI delivered propofol versus automated propofol delivery systems.
The investigators hypothesize that automated propofol delivery by CLADS will provide more
consistent anaesthesia depth maintenance as compared to TCI delivered propofol. This
randomized controlled study aims to compare the efficiency of CLADS-driven propofol TIVA
versus TCI administered in patients undergoing non-cardiac surgery with respect to adequacy
of anaesthesia depth maintenance, performance characteristic of propofol delivery system
hemodynamic stability, recovery from anaesthesia and postoperative sedation.