Evaluation of Medasense's PMD-200 During Surgery and Post Anesthesia Care

Medasense's Pain Monitoring Device (PMD) is a novel non-invasive, bedside stand alone, continuous monitor that is designed to provide real-time information about changes in the nociception level of patients under general anesthesia during surgical procedures.

The PMD-200 System is based on real-time data acquisition and processing of physiological signals. The system displays the NOL index (a single numerical index) which is computed from recorded physiological parameters based on a proprietary algorithm.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain; Surgery; Nociceptive Pain
• Intervention / Treatment: Device: PMD-200

Detailed Description

The aim of this observational study is to evaluate the pattern of the NOL index during surgery in the anesthetized patient and during the post-operative period in the awake patient.

Up to 100 patients scheduled for elective surgery under general, regional and local anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria, will be enrolled after signing informed consent.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Up to 100 patients scheduled for elective surgery under general, regional and local anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria, will be enrolled after signing informed consent.

Description

Inclusion Criteria:

• Both genders
• Age 18 - 75 years
• ASA physical status 1-3
• Elective surgery

Exclusion Criteria:

• History of severe cardiac arrhythmia
• Abuse of alcohol or illicit drugs
• Preoperative opioid consumption for > 1 week
• History of mental retardation or any mental disease diagnosis
• Under sedation protocol - Patients with difficult spontaneous ventilation ( for e.g. patients with sleep apnea) will be excluded.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ability of NOL index to change in response to noxious and non noxious stimuli as well as in response to analgesic administration.		At time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion
Specificity and sensitivity of the NOL index for detecting nociception as evaluated by receiver operating characteristics curve (ROC) analysis.	The calculated area under the graph of change in NOL values in response to a painful stimulus, as mentioned in Outcome 1.	At time of surgery, between the anaesthesia induction and extubation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in NOL Index in response to pre-defined non noxious and noxious stimuli during surgery in the anesthetized patient.	Pre-defined noxious events - laryngoscopy and intubation, skin incision or first trocar.	At time of surgery: pre-defined non noxious period - a period of 2 minutes with no noxious event with a minimal time period of 3 min prior and following laryngoscopy and intubation, skin incision or first trocar insertion.
The change in NOL index in response to administration of analgesics.		At time of surgery, 1min before versus 1 min after administration of analgesics drugs.
Total fentanyl administration during surgery and anaesthesia and frequency of bolus administration.		At time of surgery, between the anaesthesia induction and extubation.
Total time with mean arterial pressure (MAP) < 65 mmHg and correlation to NOL values during surgery and anaesthesia.		At time of surgery, between the anaesthesia induction and extubation.
Total analgesics administration during PACU (arrival to discharge) and frequency of administration		Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
NOL values during stay in PACU in the awake patient (arrival to discharge)	The NOL will be calculated via the investigational device.	Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Patients' NRS (numerical rating scale ) values during stay in PACU (arrival to discharge).	NRS will be recorded every 15 min in the PACU	Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Sedation scores during stay in PACU (arrival to discharge).	Sedation scores will be recorded every 30 min in the PACU	Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Time to first analgesic request or administration in PACU.		Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Number of opioid adverse effects in PACU (nausea and vomiting, pruritus, desaturation, respiratory depression, apnea).		Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Time of readiness to discharge from PACU	This time will be recorded since it may be different from the actual time of discharge which may be prolonged due to non-medical reasons.	Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
The correlation between NOL values during surgery and anesthesia to NOL values during the post-operative period.	The NOL will be calculated via the investigational device.	From the anaesthesia induction till the discharge from the PACU, an average of 5-6 hours.

Collaborators and Investigators

• Sponsor: Medasense Biometrics Ltd
• Investigators: Principal Investigator: Ruth Edry, MD, Rambam Health Care Campus

Publications and helpful links

General Publications

• Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
• Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.
• Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
• Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (ACTUAL): September 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nociceptive Pain
• Other Study ID Numbers: CLI-17-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No