MDoloris has reached a major new milestone in the control of peri-operative nociception, in close collaboration with Lille University Hospital and with the support of SATT Nord.
The culmination of almost 20 years of R&D and commercial development through the start-up MDoloris, the creation of an automated system for regulating perioperative pain based on continuous optimisation of para-sympathetic tone is what the company says is a world first.
Closed-loop control systems are still rare in anaesthesia today, but they provide greater reliability in achieving set objectives, reduce the risk of human error and free the anaesthetist from the burden of manually adapting the administration of the various therapies required for surgery.
Today, the administration of certain drugs is carried out by concentration-targeted perfusion systems controlled by the anaesthetist. In theory, these systems maintain a constant concentration of active ingredient in the brain tissue, according to targets set continuously by the anaesthetist, who remains involved by constantly adapting concentrations to the patient's intra-operative needs.
The MDoloris closed-loop control system uses direct measurements of the effect of drugs on the patient's autonomic nervous system - in this case, the measurement of para-sympathetic tone thanks to MDoloris technology - to constantly optimise morphine administration to the patient's needs.
The continuously measured state provides feedback for subsequent dose control. This enables the anaesthetist to concentrate on other essential tasks during surgery, such as monitoring vital physiological signals, dealing with blood loss, any anti-infectious therapies or modifying the infusion doses of other drugs used.
In practice, the algorithm developed by MDoloris is based on analysis of changes in the ANI index and blood pressure and enables to continuously personalise morphine administration during general anaesthesia according to patients' instantaneous needs.
This sentinel system detects the pain phenomenon induced by the surgical procedure and automatically administers the right dose of treatment at the right time, and for the necessary and sufficient duration.
Considering that the quality of anaesthesia influences the therapeutic success of surgery, it's easy to appreciate the importance of this technological advance.
Dr. Matthieu Jeanne, PhD, chief of anaesthesia and intensive care, Burn Treatment Centre, principal investigator of the prospective randomised clinical validation study said: "This world first is an important step forward for the practice of anaesthesia in general. This closed loop is the best companion for the surgeon, the anaesthetist, and the patient, since all three can be assured that the operation will be carried out in the best conditions of patient comfort and pain control."
Fabien Pagniez founder and CEO of MDoloris added: "MDoloris is particularly proud to be associated with this discovery, which further strengthens its role as a pioneer and leader in the measurement of pain in anaesthesia. Through its proprietary ANI index, this biological parameter, which represents the activity of the parasympathetic nervous system and enables, among other things, the measurement of nociception induced by surgery, is now expressing its full therapeutic potential through the development of this closed-loop system. Clinical validation of MDoloris closed-loop technology promises a quantum leap in patient benefit, not only during surgery, but also in the post-operative phase and beyond. The simplification of personalised anaesthesia is underway, and the Medicine of the Future is now a reality.’’
