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

NCT ID: NCT01633320

Last Updated: 2012-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Keywords

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Analgesia/Nociception index

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Edouard Herriot

OTHER

Sponsor Role lead

Responsible Party

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Emmanuel Boselli

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lionel Bouvet, MD

Role: PRINCIPAL_INVESTIGATOR

Édouard Herriot hospital, HCL

Gérard Bégou, MD

Role: PRINCIPAL_INVESTIGATOR

Édouard Herriot hospital, HCL

Rabia Dabouz, MD

Role: PRINCIPAL_INVESTIGATOR

Édouard Herriot hospital, HCL

Christophe Magnin, MD

Role: PRINCIPAL_INVESTIGATOR

Édouard Herriot hospital, HCL

Bernard Allaouchiche, MD, PhD

Role: STUDY_CHAIR

Édouard Herriot hospital, HCL

Emmanuel Boselli, MD, PhD

Role: STUDY_DIRECTOR

Édouard Herriot hospital, HCL

Mirela-Daniela Ionescu, MD

Role: PRINCIPAL_INVESTIGATOR

Édouard Herriot hospital, HCL

Locations

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Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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CPP 2012-021 B

Identifier Type: -

Identifier Source: org_study_id