NCT02305576

Brief Summary

The Analgesia Nociception Index (ANI) is a new unitless marker derived from Heart Rate Variability spectral analysis, ranging between 0 and 100 and expressing the parasympathetic tone. The ANI is proposed as surrogate marker for the analgesia nociception balance. However, many perioperative factors such as medications, position, maneuvers may influence the ANI values and may lead to misinterpretation. Moreover the ability of the ANI to guide opioid dosing has never been tested. Therefore, the aim of our study is to collect in a database all the perioperative factors and to study their influence on the ANI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

5 years

First QC Date

November 27, 2014

Last Update Submit

July 16, 2018

Conditions

Intraoperative Neurophysiological Monitoring

Outcome Measures

Primary Outcomes (1)

  • Variation of the ANI index

    Before and 2 minutes afer the factor occurrence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patietns undergoing planned surgery under general anesthesia

You may qualify if:

  • Patients undergoing scheduled surgery

You may not qualify if:

  • Non sinusal rhythm
  • Pace maker or defibrillator holders
  • Pregnancy or feeding
  • American Society of Anesthesiology physical status 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, Calvados, 14000, France

RECRUITING

Study Officials

  • Georges Daccache, M.D

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GEORGES DACCACHE, M.D

CONTACT

+ 33 2 31 06 47 36daccachg@chu-caen.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 2, 2014

Study Start

January 1, 2014

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

FR(1)