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Clinical Trials/NCT01633320
NCT01633320
Completed
Not Applicable

Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study

Hôpital Edouard Herriot1 site in 1 country200 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Hôpital Edouard Herriot
Enrollment
200
Locations
1
Primary Endpoint
Pain Scores on a 0-10 Numeric Rating Scale (NRS)
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
July 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emmanuel Boselli

MD, PhD

Hôpital Edouard Herriot

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

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.

Study Sites (1)

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