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Monitoring Analgesia by ANI (Analgesia The Nociception Index) (ANI-MICI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749304
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Nociceptive Pain Surgical Procedure, Unspecified Device: ANI monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel
Actual Study Start Date : March 16, 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ANI monitor Device: ANI monitor
experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749304


Locations
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France
Hôpital Claude Huriez, CHU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Gilles Lebuffe, MD, PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03749304    
Other Study ID Numbers: 2012_31
2012-A01363-40 ( Other Identifier: ID-RCB number, ANSM )
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nociceptive Pain
Pain
Neurologic Manifestations
Signs and Symptoms