Evaluation of Automated Propofol Delivery in Patients Undergoing Thoracic Surgery

• Status: Completed
• Trial end date: 2019-06-25
• Target enrollment: 0
• Participant gender: All

Summary

Automated delivery of propofol using computer-controlled closed loop anaesthesia device delivers propofol based on patient's frontal cortex electrical activity as determined by bi-spectral 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.

By automatically controlling anaesthesia depth consistency they provide time to the anaesthesiologist to focus on other aspects of patient care such as managing intra-operative hemodynamics and ventilation perturbations during major surgeries.

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. Although a few studies have already evaluated these automated systems in patients undergoing thoracic surgery, but suffered from significant limitations (small number of patients, not dedicated to thoracic surgery cohort). Currently, there is no data available regarding CLADS performance vis a vis adequacy of GA and haemodynamic profile in patients undergoing thoracic surgery.

We contend that propofol as delivered by CLADS will proffer greater consistency to anaesthesia depth, intra-operative hemodynamic stability, and rapid recovery upon anaesthesia discontinuation than manual means of delivering propofol TIVA. This randomised controlled study aims to compare the efficiency of CLADS-driven propofol TIVA versus manually controlled propofol TIVA in patients undergoing thoracic surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Nitin Sethi
• Treatments: Anesthetics; Propofol

Criteria

Inclusion Criteria:

• ASA physical status I-III

• undergoing unilateral open thoracic surgery or unilateral video-assisted thoracic surgery (VATS) Exclusion Criteria:

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

• Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism)

• Known allergy/hypersensitivity to the study drug

• Drug dependence/substance abuse

• Requirement of postoperative ventilation

• Refusal to informed consent