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NCT02305576 Clinical Trial

Effect of Perioperative Factors on the Analgesia Nociception Index

Intraoperative Neurophysiological Monitoring Clinical Trial

— ANIFACT  

Official title:
Effect of Perioperative Factors on the Analgesia Nociception Index

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02305576
Other study ID # 13-181
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2014
Est. completion date December 31, 2018

Study information
Verified date July 2018
Source University Hospital, Caen
Contact GEORGES DACCACHE, M.D
Phone + 33 2 31 06 47 36
Email daccachg@chu-caen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing scheduled surgery

Exclusion Criteria:

- Non sinusal rhythm

- Pace maker or defibrillator holders

- Pregnancy or feeding

- American Society of Anesthesiology physical status 4

Study Design

Related Conditions & MeSH terms

  • Intraoperative Neurophysiological Monitoring

Locations
Country Name City State
France Caen University Hospital Caen Calvados

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variation of the ANI index Before and 2 minutes afer the factor occurrence
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