Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)

This study has been completed.
Sponsor:
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
  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)
Detailed Description:

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 April 16, 2014