Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)
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|ClinicalTrials.gov Identifier: NCT01633320|
Recruitment Status : Completed
First Posted : July 4, 2012
Results First Posted : December 18, 2012
Last Update Posted : December 18, 2012
|Condition or disease|
Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression.
Assessment of the performance of ANI to detect NRS>3 and NRS>=7 by building ROC curves.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
- Analgesia/Nociception Index (ANI) [ Time Frame: At arrival in post-operative care unit (PACU) or 10 min after extubation ]The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.
- Pain Scores on a 0-10 Numeric Rating Scale (NRS) [ Time Frame: At arrival in PACU or 10 min after extubation ]Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS<3 corresponds to no or mild pain NRS>=3 corresponds to moderate to severe pain NRS>=7 corresponds to severe pain
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633320
|Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL|
|Lyon, France, 69003|
|Principal Investigator:||Lionel Bouvet, MD||Édouard Herriot hospital, HCL|
|Principal Investigator:||Gérard Bégou, MD||Édouard Herriot hospital, HCL|
|Principal Investigator:||Rabia Dabouz, MD||Édouard Herriot hospital, HCL|
|Principal Investigator:||Christophe Magnin, MD||Édouard Herriot hospital, HCL|
|Study Chair:||Bernard Allaouchiche, MD, PhD||Édouard Herriot hospital, HCL|
|Study Director:||Emmanuel Boselli, MD, PhD||Édouard Herriot hospital, HCL|
|Principal Investigator:||Mirela-Daniela Ionescu, MD||Édouard Herriot hospital, HCL|