Performance Analysis of Hermetic Closed-loop Anesthesia Delivery System
Status:
Recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
Total intravenous anaesthesia (TIVA) is now a preferred technique for providing general
anaesthesia (GA) because of its various inherent advantages like reduced postoperative nausea
and vomiting (PONV), improved quality of post-operative recovery, anti-inflammatory and
antioxidant action, anti-neoplastic activity, analgesic action, and absence of greenhouse
effect. The evolution and advancement in automated anaesthesia delivery systems particularly
for propofol have made propofol-TIVA more efficient by removing the human interface for both
rate and concentration adjustments. Automated computer-controlled closed loop anaesthesia
device adjusts propofol delivery based on patient's frontal cortex electrical activity
determined by bispectral index (BIS).
Closed loop anaesthesia delivery system (CLADS) is an indigenously developed patented (Patent
no.502/DEL/2003 & US 9,108,013 B2) computer-controlled anaesthesia delivery system which
works with feedback loop information elicited by BIS monitoring and delivers propofol TIVA to
the patient via a non-TCI automated infusion pump. It has been an extensively used and
validated in patients undergoing both cardiac and non-cardiac surgical procedures.
A new compact and upgraded version of CLADS is now available. This new version incorporates
the anesthetic depth monitor, hemodynamic monitor, controller, user interface and actuator
syringe pump into a single, compact and user-friendly module.
The investigators aim to conduct a prospective randomized pilot study comparing the new CLADS
and older CLADS version with respect to: adequacy of anaesthesia depth maintenance,
performance characteristic of propofol delivery system, propofol requirement, haemodynamics
stability, recovery from anesthesia and postoperative sedation.