Monitoring Analgesia by ANI (Analgesia The Nociception Index) (ANI-MICI)

November 21, 2018 updated by: University Hospital, Lille

Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Claude Huriez, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANI monitor
Device: ANI monitor
experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of ANI greater than 20 points
Time Frame: During the surgery, an average Three hours and a half
ANI decrease greater than 20 points between a "NoStim" period before surgical incision under general anesthesia and a period of intraoperative "ReactHemo" hemodynamic reactivity defined by a 20% increase in FC and / or PAS.
During the surgery, an average Three hours and a half

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Gilles Lebuffe, MD, PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

November 26, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012_31
  • 2012-A01363-40 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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