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

NCT03276260 | Terminated

• 1 other identifier: CLI-17-02
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; Nociceptive Pain; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• The change in NOL Index in response to pre-defined non noxious and noxious stimuli during surgery in the anesthetized patient.

  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.

Interventions

PMD-200 DEVICE

Patient will be connected to PMD-200 by finger-probe before induction of anesthesia or sedation. Recording will continue during surgery until extubation or awakening. Recording will be initiated again as soon as the patient arrives to the PACU until discharge to the surgical ward or home.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medasense Biometrics Ltd: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Related Publications (4)

• 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.

  PMID: 27171828 BACKGROUND

• 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.

  PMID: 26154185 BACKGROUND

• 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.

  PMID: 22647429 BACKGROUND

• 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.

  PMID: 23835792 BACKGROUND

MeSH Terms

Conditions

Nociceptive Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Ruth Edry, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: September 8, 2017
• Study Start: January 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)