Performance Analysis of Hermetic Closed-loop Anesthesia Delivery System

NCT ID: NCT05967403

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-09
• Study Completion Date: 2026-11-30

Brief 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.

Detailed Description

Propofol total intravenous anaesthesia (TIVA) is a preferred technique for providing induction and maintenance of general anaesthesia (GA). As opposed to the conventional inhaled anesthetics for maintaining GA, propofol TIVA has several advantages, such as, lower incidence of postoperative nausea and vomiting (PONV), antinociceptive and anti-inflammatory action, anti-neoplastic activity, and most importantly, its environment disposition (no greenhouse effect); and therefore, has potential to replace inhaled vapors for GA.

The introduction of target-controlled infusion (TCI) pumps has allowed precision control in propofol delivery as compared to the conventional manually operated infusion pumps. In manually operated infusion pumps the clinician regulates the propofol infusion rate to achieve the desired anaesthesia depth, whereas TCI-pumps deliver propofol using inbuilt algorithms based on the pharmacokinetic (PK) and pharmacodynamic (PD) profile of propofol. Two of the most used PK-PD models for propofol delivery are the Marsh model and the Schneider model. Whereas in the Marsh model the user can set the desired target plasma concentration, Schneider model allows the user to set the desired target effect site concentration for achieving adequate depth of GA.

Over the last two decades the evolution and advancement in automated anaesthesia delivery systems, particularly for propofol administration, has made propofol-TIVA delivery more efficient by removing the human interface required for adjusting real-time propofol delivery, both rate and concentration of propofol. Automated anaesthesia delivery systems deliver propofol based on ascertaining frontal cortex electrical activity as determined by the processed electroencephalogram, the bispectral index (BIS) score. These devices regulate propofol delivery based on a feedback loop involving the BIS score (control variable) generated by the patient and the propofol infusion pump (actuator) and attempts to keep the values within a pre-assigned range, consistent with robust GA depth.

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. The basic control algorithm is based on the relationship between the infusion rates of propofol and BIS values, taking into consideration the pharmacokinetic variables, such as, drug distribution and clearance. The system updates the EEG data every 5-seconds and calculates the BIS error, a difference between the target BIS and the actual BIS value using the proportional-integral-derivative (PID) controller. During anaesthesia induction the target concentration is achieved in a stepwise manner with BIS feedback received every 5-seconds. During maintenance phase of anaesthesia, the propofol delivery is modified every 1-epoch of 30-seconds duration. In each epoch an average of initial 3-BIS values (of every 5-seconds) and average of last 3-BIS values (of every 5-seconds) are compared, and a trend assessment is made. If the trend indicates increasing BIS values, then higher propofol rate is delivered by the infusion pump (actuator) and vice-versa. The control algorithm is implemented using a personal computer (PC) with a Pentium 4 processor. The PC controls communication with the infusion pump (Pilot-C, Fresenius, Paris, France) and the vital sign monitor (AS5, Datex Ohmeda Division, GE Healthcare, Singapore) through RS 232 serial ports.

CLADS has been extensively used and validated for administering propofol TIVA in patients undergoing both cardiac and non-cardiac surgical procedures. In a multi-centric study on evaluation of anaesthesia delivery by CLADS, it was shown that CLADS maintains depth of anaesthesia with far more precision as compared to manual administration.

A new compact and upgraded version of CLADS (Clarity Medical Private Ltd., Mohali, Punjab Indiais now available. The new version integrates the anaesthetic depth as well as the hemodynamic monitor, the controller, the user interface and the actuator syringe pump into a single, compact and user-friendly module.

The investigators aim to conduct a prospective randomised pilot to compare the multiple connected-unit conventional CLADS with the hermetically unit-integrated CLADS version, with respect to, the adequacy of anaesthesia depth (primary objective); and, performance characteristic, propofol requirement, haemodynamic stability, recovery from anaesthesia and postoperative sedation of the delivery systems (secondary objectives).

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Conventional CLADS group

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

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Hermetic CLADS group

Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the hermetic closed-loop anaesthesia delivery system (CLADS).\[(Clarity Medical Private Ltd., Mohali, Punjab India\]. A BIS value of 50 will be used as the target point for induction and maintenance of anesthesia

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Ganga Ram Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nitin Sethi, DNB

Senior Consultant, Institute of Anaesthesiology, Pain & Perioperative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nitin Sethi, DNB

Role: STUDY_DIRECTOR

Sir Ganga Ram Hospital, New Delhi, INDIA

Amitabh Dutta, MD, PGDHR

Role: PRINCIPAL_INVESTIGATOR

Sir Ganga Ram Hospital, New Delhi, INDIA

Goverdhan D Puri, MD, PhD

Role: STUDY_CHAIR

Post Graduate Institute of Medical Education & Research, Chandigarh, India

Locations

Nitin Sethi

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Amitabh Dutta, MD, PGDHR

Role: CONTACT

duttaamitabh@yahoo.co.in

+919810848064

Nitin Sethi, DNB

Role: CONTACT

nitinsethi77@yahoo.co.in

+919717494498

Facility Contacts

Nitin Sethi, DNB

Role: primary

nitinsethi77@yahoo.co.in

009142252523

Other Identifiers

EC/05/23/2282

Identifier Type: -

Identifier Source: org_study_id