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

University Hospital, Lille1 site in 1 country25 target enrollmentMarch 16, 2014

ConditionsNociceptive Pain Surgical Procedure, Unspecified

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nociceptive Pain
Sponsor: University Hospital, Lille
Enrollment: 25
Locations: 1
Primary Endpoint: Change of ANI greater than 20 points
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 16, 2014

End Date

March 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change of ANI greater than 20 points

Time Frame: During the surgery, an average Three hours and a half

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.