Monitoring Analgesia by ANI (Analgesia The Nociception Index)

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).

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Key information

Conditions

Nociceptive Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgical Procedure, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Claude Huriez, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANI monitor

Device

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

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: ANI-MICI

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Nov 21, 2018
Registry last updated: Nov 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed