Impact of NOL Intraoperative Guided Fentanyl Analgesia vs SCC for Elective Major Abdominal Surgery
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|ClinicalTrials.gov Identifier: NCT03970291|
Recruitment Status : Not yet recruiting
First Posted : May 31, 2019
Last Update Posted : August 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Device: PMD-200||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Nociceptive-Level (NOL) Intraoperative Guided Fentanyl Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||February 27, 2020|
Experimental: Nociceptive-Level (NOL)
Analgesic component of anesthesia (fentanyl) will be guided using NOL
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)
No Intervention: Standard Clinical Care (SCC)
Standard Clinical Care guided fentanyl administration
- Pain score [ Time Frame: Through study completion, about 8 months ]Change in pain score in the PACU using the visual analog scale (VAS)
- Hypotension episodes [ Time Frame: Through study completion, about 8 months ]Change of hypotension episodes (MAP < 55 mmHg and/or < 60 mmHg) during the maintenance period until reversal
- Inadequate analgesia/anesthesia events [ Time Frame: Through study completion, about 8 months ]Change in frequency of Inadequate analgesia/anesthesia events*
- Total intraoperative fentanyl [ Time Frame: Through study completion, about 8 months ]Change in total intraoperative fentanyl consumption (in mcg).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970291
|Contact: Rachel Weissbrodfirstname.lastname@example.org|
|Shaare Zedek Medical Center||Not yet recruiting|
|Contact: Rivka Leah Fuica, MD 972-2-6555104 email@example.com|
|Principal Investigator: Rivka Leah Fuica, MD|
|Principal Investigator:||Dr Rivka Leah Fuica, MD||Shaare Zedek|