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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03276260
• Other study ID #: CLI-17-02
• Status: Terminated
• Start date: January 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: March 2020
• Source: Medasense Biometrics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nociceptive Pain
• Postoperative Pain
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Medasense Biometrics Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Treister R, Kliger M, Zuckerman G, Goor Aryeh I, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-14. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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.
Secondary	Total fentanyl administration during surgery and anaesthesia and frequency of bolus administration.		At time of surgery, between the anaesthesia induction and extubation.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.