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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01633320
First Posted: July 4, 2012
Last Update Posted: December 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Emmanuel Boselli, Hôpital Edouard Herriot
  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 Emmanuel Boselli, 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 ]
    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


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Emmanuel Boselli, MD, PhD, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier: NCT01633320     History of Changes
Other Study ID Numbers: CPP 2012-021 B
First Submitted: June 28, 2012
First Posted: July 4, 2012
Results First Submitted: August 6, 2012
Results First Posted: December 18, 2012
Last Update Posted: December 18, 2012
Last Verified: November 2012

Keywords provided by Emmanuel Boselli, Hôpital Edouard Herriot:
Analgesia/Nociception index

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms