CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
fentanyl NOL guideddrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03858621
NCT03858621N/ACompleted

Comparison of Postoperative Nociception Outcomes Between NOL - Guided and Standard Intraoperative Analgesia Based on Fentanyl in Patients Undergoing Elective Surgery With General Anesthesia

Victor Contreras, MSN·interventional·Posted Mar 1, 2019·Updated Mar 8, 2022

In Brief

A clinical study evaluating fentanyl NOL guided for Pain, Postoperative and 6 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Pain is defined as an unpleasant sensory and emotional conscious experience, associated with actual or potential tissue damage. Nociception is the sympathetic response to noxious stimuli during unconsciousness. The appearance of different forms of chronic pain results from sensitization of both peripheral and central neural circuits of pain, which involves inflammatory mechanisms both at a systemic level and specifically in the peripheric and central nervous system, as observed through elevation of specific neuroinflammatory mediators, such as MCP-1, IL-1, IL-1b, and IL-10. Clinically, this sensitization expresses as hyperalgesia and allodynia, which increase postoperative pain and morbidity, but also induce permanent modifications in the nociceptive system. These effects may be ameliorated by adequately adjusting intraoperative analgesia through use of nociception/analgesia balance monitors, of which Nociception Level Index (NOL) shows convenient characteristics and promising results from previous studies. Objectives: The goal of our study is to assess the utility of NOL index monitoring against standard care for Fentanyl-based analgesia by measuring postoperative pain, sensorial thresholds and inflammatory markers related to nociception. Hypothesis: The use of NOL index to guide the intraoperative analgesia will produce less postoperative pain, hyperalgesia, allodynia, and neuroinflammation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 1, 2019
Enrollment StartMar 15, 2019
Primary CompletionFeb 23, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.3 years ago

Interventions

fentanyl NOL guideddrug

Intervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery.