An observational study in Surgery, Nociceptive Pain and Postoperative Pain, sponsored by Medasense Biometrics Ltd. Terminated at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-11.
Sponsored by Medasense Biometrics Ltd · Observational
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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.
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.
96 studies on the registry are indexed under Nociceptive Pain; 18 are open to participants now.
This study's enrollment of 2 is below the median of 74 across 32 observational studies indexed under Nociceptive Pain.
Browse Nociceptive Pain studies →Medasense Biometrics Ltd is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Total analgesics administration during PACU (arrival to discharge) and frequency of administration
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: From the anaesthesia induction till the discharge from the PACU, an average of 5-6 hours.
Plan to share: No
Ran from Jan 2018 to primary completion in Apr 2019, 15 months.
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This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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