Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)
This study has been completed.
Sponsor:
Hôpital Edouard Herriot
Information provided by (Responsible Party):
Emmanuel Boselli, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier:
NCT01633320
First received: June 28, 2012
Last updated: November 13, 2012
Last verified: November 2012
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Purpose
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.
| Condition |
|---|
|
Postoperative Pain |
| Study Type: | Observational |
| 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 |
Further study details as provided by Hôpital Edouard Herriot:
Primary Outcome Measures:
- 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
| Enrollment: | 200 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult patients underoing surgical or endoscopic procedures performed on general anesthesia
Criteria
Inclusion Criteria:
- adult
- surgical or endoscopic procedures performed on general anesthesia
Exclusion Criteria:
- age <18 yrs or >75 yrs
- arrythmia
- administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
- psychiatric diseases
- autonomic nervous system (ANS) disorders
- inability to understand the verbal rating pain scale.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633320
Locations
| France | |
| Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL | |
| Lyon, France, 69003 | |
Sponsors and Collaborators
Hôpital Edouard Herriot
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Emmanuel Boselli, MD, PhD, Hôpital Edouard Herriot |
| ClinicalTrials.gov Identifier: | NCT01633320 History of Changes |
| Other Study ID Numbers: | CPP 2012-021 B |
| Study First Received: | June 28, 2012 |
| Results First Received: | August 6, 2012 |
| Last Updated: | November 13, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hôpital Edouard Herriot:
|
Analgesia/Nociception index |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013