Monitoring Analgesia by ANI (Analgesia The Nociception Index)

Not Applicable

Completed

• Conditions: Surgical Procedure, Unspecified; Nociceptive Pain

• Registration Number: NCT03749304
• Lead Sponsor: University Hospital, Lille

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-16
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2018-11
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-21
• Last Update Submitted: 2018-11-21
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change of ANI greater than 20 points	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.

Trial Locations

Locations (1)

Hôpital Claude Huriez, CHU; 🇫🇷 Lille, France