Performance Analysis of Hermetic Closed-loop Anesthesia Delivery System

ConditionAnesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSir Ganga Ram Hospital

About this trial

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.

Eligibility criteria

Qualifiers

aged 18-65 years-

ASA physical status I-II

undergoing elective non-cardiac surgery of minimum 60-minutes duration

Disqualifiers

Uncompensated cardiovascular disease (e.g., uncontrolled hypertension, atrio- ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction).

Hepato-renal insufficiency.

Any history of neurological disorder (e.g., epilepsy) or brain trauma

Uncontrolled endocrine diseases (e.g., diabetes mellitus, hypothyroidism).

Trial design

Treatments tested in this trial

  • Propofol
  • Propofol

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators