CClinicalTrials.gg
Status unknownNCT02305576ANIFACTUpdated Jul 17, 2018

Effect of Perioperative Factors on the Analgesia Nociception Index

An observational study in Intraoperative Neurophysiological Monitoring, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by University Hospital, Caen · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Intraoperative Neurophysiological Monitoring
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In context

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patietns undergoing planned surgery under general anesthesia

Inclusion criteria

  • Patients undergoing scheduled surgery

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Variation of the ANI index

    Time frame: Before and 2 minutes afer the factor occurrence

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Study locations

1 of 1 sites recruiting
  • Caen University Hospital
    Caen, Calvados 14000, France
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02305576
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Dec 2, 2014
Start date
Jan 2014
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Jul 17, 2018

Study contacts

GEORGES DACCACHE, M.D
Contact
daccachg@chu-caen.fr
+ 33 2 31 06 47 36
Georges Daccache, M.D
principal investigator · University Hospital, Caen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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