NCT03749304

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

3 years

First QC Date

November 20, 2018

Last Update Submit

November 21, 2018

Conditions

Nociceptive PainSurgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

  • 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.

    During the surgery, an average Three hours and a half

Study Arms (1)

ANI monitor

EXPERIMENTAL
Device: ANI monitor

Interventions

ANI monitorDEVICE

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

ANI monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

Location

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gilles Lebuffe, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 21, 2018

Study Start

March 16, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

November 26, 2018

Record last verified: 2018-11

Locations

FR(1)