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Monitoring Analgesia by ANI (Analgesia The Nociception Index)

Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03749304
Acronym
ANI-MICI
Enrollment
25
Registered
2018-11-21
Start date
2014-03-16
Completion date
2017-03-31
Last updated
2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nociceptive Pain, Surgical Procedure, Unspecified

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).

Interventions

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of ANI greater than 20 pointsDuring the surgery, an average Three hours and a halfANI 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026