RecruitingNot ApplicableNCT05967403

Performance Analysis of Hermetic Closed-loop Anesthesia Delivery System

Anaesthesia Depth Consistency and System Performance of a Hermetic Closed-loop Anaesthesia Delivery System: A Randomized Controlled Study

Sponsor

Sir Ganga Ram Hospital

Enrollment

150 participants

Start Date

Dec 9, 2023

Study Type

INTERVENTIONAL

Conditions

Anesthesia

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

aged 18-65 years-
ASA physical status I-II
undergoing elective non-cardiac surgery of minimum 60-minutes duration

Exclusion Criteria8

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).
Known allergy/hypersensitivity to the study drug.
History of any psychiatric disorder and/or drug dependence/substance abuse.
Requirement of postoperative ventilation.
Refusal to informed consent.

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Interventions

DRUGPropofol

Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the conventional closed loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.

DRUGPropofol

Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the hermetic closed loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.