Monitoring Analgesia by ANI (Analgesia The Nociception Index)

NCT ID: NCT03749304

Last Updated: 2018-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-16

Study Completion Date

2017-03-31

Brief Summary

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The objective of this research is to study the variations of the ANI(Analgesia The Nociception Index) according to 2 periods: the "NoStim" period before surgical incision under general anesthesia and the period of hemodynamic reactivity "ReactHemo" peroperative. This period is defined by a 20% increase in FC and / or PAS (the only gold standard today).

Detailed Description

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Conditions

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Nociceptive Pain Surgical Procedure, Unspecified

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ANI monitor

Group Type EXPERIMENTAL

ANI monitor

Intervention Type DEVICE

experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index

Interventions

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ANI monitor

experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patient with IBD
* Scheduled surgery: laparotomy or laparoscopic resection with high risk of laparo-conversion

Exclusion Criteria

* patient included in another current study or the previous month
* urgent surgery
* toxicomania or receiving opioids preoperatively
* pregnant woman
* psychosis
* betablocker treatment
* diabetic dysautonomia
* non-sinus heart rate
* pacemaker heart transplant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Lebuffe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Claude Huriez, CHU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2012-A01363-40

Identifier Type: OTHER

Identifier Source: secondary_id

2012_31

Identifier Type: -

Identifier Source: org_study_id

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