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

Medasense Biometrics Ltd2 enrolled

Overview

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.

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

Conditions

Surgery Nociceptive Pain Postoperative Pain

Interventions

PMD-200DEVICE

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

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rambam Health Care Campus

Haifa, Israel

Outcomes

Primary Outcomes

The ability of NOL index to change in response to noxious and non noxious stimuli as well as in response to analgesic administration.

Time frame: 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.

Time frame: At time of surgery, between the anaesthesia induction and extubation.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At time of surgery, between the anaesthesia induction and extubation.

Data from ClinicalTrials.gov

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