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

Primary Purpose

Nociceptive Pain, Surgical Procedure, Unspecified

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ANI monitor
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nociceptive Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Claude Huriez, CHU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ANI monitor

Arm Description

Outcomes

Primary Outcome Measures

Change of ANI greater than 20 points
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.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2018
Last Updated
November 21, 2018
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03749304
Brief Title
Monitoring Analgesia by ANI (Analgesia The Nociception Index)
Acronym
ANI-MICI
Official Title
Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 16, 2014 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nociceptive Pain, Surgical Procedure, Unspecified

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ANI monitor
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ANI monitor
Intervention Description
experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index
Primary Outcome Measure Information:
Title
Change of ANI greater than 20 points
Description
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.
Time Frame
During the surgery, an average Three hours and a half

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Lebuffe, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Claude Huriez, CHU
City
Lille
Country
France

12. IPD Sharing Statement

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Monitoring Analgesia by ANI (Analgesia The Nociception Index)

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