Performance Analysis of Hermetic Closed-loop Anesthesia Delivery System

NCT05967403 · tracked via the Priya Life Science India tracker

Sponsor

Sir Ganga Ram Hospital

Phase

Not applicable

Started

2023-12-09

Last updated

2026-04-27

Condition(s) studied

Anesthesia

Investigational drug(s) / intervention(s)

Propofol →Propofol →

Propofol: 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.

Propofol: 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * aged 18-65 years- * ASA physical status I-II * undergoing elective non-cardiac surgery of minimum 60-minutes duration Exclusion Criteria: * 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.

Primary outcome measure(s)

Anaesthesia depth consistency — From beginning of anaesthesia till 5- minutes post skin closure
It will be determined by the percentage of the anaesthesia time during which the BIS remained +/- 10 of the target BIS of 50

Trial sites (1)

Facility	City	Region	Status
Nitin Sethi	New Delhi	National Capital Territory of Delhi	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05967403 on ClinicalTrials.gov ↗ ← All trials in India