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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Surgery, Nociceptive Pain, Postoperative Pain

Intervention / Treatment
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* Device: PMD-200


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PMD-200|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.|

What is the study measuring?
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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. |