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Recently, a newly developed index, the Nociceptive Level (NOL) index, was validated and showed superiority over heart rate and blood pressure for recognition and grading of intense and mild nociceptive stimuli during surgery under general anesthesia.
We hypothesize that compared with standard management, NOL-guided anesthesia will lead to reduced postoperative pain scores, and during anesthesia, to increased hemodynamic stability.
Uncontrolled postoperative pain may result in significant clinical, psychological, and socioeconomics consequences. Not only does inadequate pain management following surgery result in increased morbidity and mortality but it also may delay recovery, result in unanticipated readmissions, decrease patient satisfaction, and lead to chronic persistent postsurgical pain. Pain is multifactorial in nature and understanding both the complexity of pain and its side effects is imperative to achieve a successful surgical outcome.
Nociception/analgesia are currently assessed by monitoring changes in heart rate (HR), blood pressure (BP), and other indirect parameters which are not sensitive or specific to nociception. As a result, the patient may be given insufficient analgesia which can promote postoperative pain, or excessive analgesia which can result in overdosing and related complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nociceptive-Level (NOL) | Experimental | Analgesic component of anesthesia (fentanyl) will be guided using NOL |
|
| Standard Clinical Care (SCC) | No Intervention | Standard Clinical Care guided fentanyl administration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMD-200 | Device | The PMD-200 system is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Change in pain score in the PACU using the visual analog scale (VAS) | Through study completion, about 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inadequate analgesia/anesthesia events | Change in frequency of Inadequate analgesia/anesthesia events* | Through study completion, about 8 months |
| Total intraoperative fentanyl | Change in total intraoperative fentanyl consumption (in mcg). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Rivka Leah Fuica, MD | Shaare Zedek Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Jerusalem | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35976578 | Derived | Fuica R, Krochek C, Weissbrod R, Greenman D, Freundlich A, Gozal Y. Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial. J Clin Monit Comput. 2023 Apr;37(2):481-491. doi: 10.1007/s10877-022-00906-1. Epub 2022 Aug 17. |
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| Through study completion, about 8 months |