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NCT03749304 Clinical Trial

Monitoring Analgesia by ANI (Analgesia The Nociception Index)

Surgical Procedure, Unspecified Clinical Trial

— ANI-MICI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03749304
Other study ID # 2012_31
Secondary ID 2012-A01363-40
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2014
Est. completion date March 2017

Study information
Verified date November 2018
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ANI monitor
experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index

Locations
Country Name City State
France Hôpital Claude Huriez, CHU Lille

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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