Shaare Zedek Medical Center
Jerusalem, Israel
NCT Number: NCT03970291
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Jerusalem, Israel
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Through study completion, about 8 months
Change in pain score in the PACU using the visual analog scale (VAS)
Time frame: Through study completion, about 8 months
Change in frequency of Inadequate analgesia/anesthesia events*
Time frame: Through study completion, about 8 months
Change in total intraoperative fentanyl consumption (in mcg).
Medasense Biometrics Ltd
Other
Impact of Nociceptive-Level (NOL) Intraoperative Guided Fentanyl Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06993740
Anesthesia, Cardiovascular Diseases
Jakarta, DKI Jakarta, Indonesia
View Trial DetailsNCT07259629
Anesthesia, Glucose Metabolism Disorders
Exeter, Devon, United Kingdom
View Trial DetailsNCT03972423
Anesthesia, Anesthesia Complication
Versailles, IDF, France
View Trial DetailsNCT05111340
Aberrant Motor Behavior in Dementia, Anesthesia
Arras, France
View Trial Details