Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)
The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study|
- Analgesia/Nociception Index (ANI) [ Time Frame: At arrival in post-operative care unit (PACU) or 10 min after extubation ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||July 2012|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|