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

Medasense

Status: Terminated

Conditions: Postoperative Pain; Surgery; Nociceptive Pain

Treatments: Device: PMD-200

Study type: Observational

Funder types: Other

Identifiers

NCT03276260

CLI-17-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.