Comparison of TIVA by Closed Loop Anaesthesia Delivery System Versus Target Controlled Infusion Device

Summary

Total intravenous anaesthesia (TIVA) is now being adopted as a preferred technique for providing GA because of its various inherent advantages like reduced PONV incidence, improved quality of recovery post GA, anti-inflammatory and anti-oxidant action, anti-neoplastic activity, analgesic action, and absence of greenhouse effect. Over the years propofol-TIVA delivery has become more methodical due to the use of target-controlled infusion (TCI) systems. The current TCI technology has evolved with the introduction of the 'open' TCI concept wherein syringes of any configuration can be attached to the TCI-pumps having pre-programmed propofol PK-PD models. The two most commonly use propofol PK-PD models are the Marsh and Schneider models targeting the propofol blood plasma concentration and effect site concentration in the brain respectively. Automated delivery of propofol using computer-controlled closed loop anaesthesia device delivers propofol based on patient's frontal cortex electrical activity as determined by bispectral index (BIS). Evaluation of anaesthesia delivery by these systems has shown that they deliver propofol and maintain depth of anaesthesia with far more precision as compared to manual administration. A recent advance in propofol delivery has been the development of automated closed loop anaesthesia delivery system. These devices deliver propofol based on patient's frontal cortex electrical activity as determined by bispectral index (BIS).Closed loop anaesthesia delivery system (CLADS) is an indigenously developed continuous automated intravenous infusion system which delivers propofol based on patients' EEG profile (BIS) feedback. Currently there is no data available comparing the efficacy of TCI delivered propofol versus automated propofol delivery systems. The investigators hypothesize that automated propofol delivery by CLADS will provide more consistent anaesthesia depth maintenance as compared to TCI delivered propofol. This randomized controlled study aims to compare the efficiency of CLADS-driven propofol TIVA versus TCI administered in patients undergoing non-cardiac surgery with respect to adequacy of anaesthesia depth maintenance, performance characteristic of propofol delivery system hemodynamic stability, recovery from anaesthesia and postoperative sedation.

Conditions

• Anesthesia

Interventions

DRUG

Propofol

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

DRUG

Propofol

The target controlled infusion (TCI) pump will be programmed to marsh model with the target plasma site concentration of 3-µg/ml. The plasma concentration will be altered to maintain a target BIS of 50 during induction and maintenance of anesthesia

DRUG

Propofol

The target controlled infusion (TCI) pump will be programmed to Schneider model with the target effect site concentration of 3-µg/ml. The effect-site concentration will be altered to maintain a target BIS of 50 during induction and maintenance of anesthesia

DRUG

Propofol

Manual propofol administration will be done using an intravenous infusion pump to maintain a target BIS of 50 during induction and maintenance of anesthesia.

Sponsors & Collaborators

• Sir Ganga Ram Hospital

  lead OTHER

Principal Investigators

• Jayashree Sood, MBBS, MD, FFRCA, PGDHHM, FICA · Sir Ganga Ram Hospital, New Delhi, INDIA

• Goverdhan D Puri, MBBS, MD, PhD · Postgraduate Institute for Medical Education & Research, Chandigarh, India

• Nitin Sethi, MBBS, DNB · Sir Ganga Ram Hospital, New Delhi, INDIA

• Amitabh Dutta, MBBS, MD, PGDHR · Sir Ganga Ram Hospital, New Delhi, INDIA

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-02

Primary Completion

2025-06-17

Completion

2025-06-17

Countries

• India

Study Locations