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Ability of Changes in Analgesia Nociception Index to Assess the Stroke Volume Effects of a Volume Expansion of 250ml of Crystalloid in the Operating Room (REVANI)

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ClinicalTrials.gov Identifier: NCT04223414
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Volume expansion is the cornerstone of perioperative hemodynamic optimization. The main objective of volume expansion is to increase and maximize stroke volume. Hemodynamic changes have an impact on the autonomic nervous system. The analysis of heart rate variability allows an exploration of the autonomic nervous system and could therefore provide information on the effect of volume expansion. The Analgesia Nociception Index (ANI) is an analgesia monitor based on the concept of heart rate variability. By deviating from its original use, the investigators wish to evaluate the ability of ANI to identify a response to volume expansion.

Condition or disease Intervention/treatment
Volume Expansion Fluid Responsiveness Device: Analgesia Nociception Index (ANI)

Detailed Description:

Perioperative optimization is based on volume maximization using volume expansion. The main objective of volume expansion is to increase stroke volume. The Franck-Starling curve is schematically divided into two portions: a vertical portion which mean that an increase in preload secondary to volume expansion will induce an increase in stroke volume; and a flat portion where volume expansion will not induce an increase in stroke volume. Perioperative optimization is based on stroke volume maximization using volume expansion.

In case of hypovolemia, there is a compensatory sympathetic stimulation with parasympathetic withdrawal. Volume expansion will lead to an increase in venous return and therefore in cardiac output, which will result in a decrease in sympathetic tone. The autonomic nervous system is therefore directly affected by these load changes. The analysis of heart rate variability, which has been studied for several years in various setting, allows the assessment of autonomic nervous system, through monitoring of the electrocardiogram. Experimental and clinical studies report the ability of variations in heart rate variability to detect a situation of hypovolemia. In anaesthesia, heart rate variability is used to evaluate the nociception-antinociception balance. Indeed, any nociceptive stimulation leads to an increase in sympathetic tone. MetroDoloris has developed a non-invasive monitor that provides an index, the Analgesia Nociception Index (ANI), to evaluate the nociception-antinociception balance by analysing the autonomic nervous system.

In this study, the original use of ANI will be diverted from its initial use, to analyse the autonomic nervous system's response to volume expansion. Thus, the aim of the present study is to determine whether a change in Analgesia Nociception Index can track the stroke volume effects of a volume expansion using 250ml of crystalloid in the operating room.

The follow up will be restricted to the duration of surgical intervention. The last data will be collected 5 minutes after the end of volume expansion.

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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ability of Changes in Analgesia Nociception Index to Assess the Stroke Volume Effects of a Volume Expansion of 250ml of Crystalloid in the Operating Room. REVANI Trial
Actual Study Start Date : January 29, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Analgesia Nociception Index (ANI)

    ANI will be used to analyse the autonomic nervous system's response to volume expansion.

    ANI will be assessed during surgery, before during and after the volume expansion



Primary Outcome Measures :
  1. ANI value variation (%) before and after the volume expansion [ Time Frame: 5 minutes after volume expansion ]
    Changes in the analgesia nociception index during a volume expansion of 250 mL crystalloid during 10 minutes in patients who responded to volume expansion (stroke volume increase by 10% or more after volume expansion) and in patients who did not respond to volume expansion (stroke volume increase less than 10% after volume expansion).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient scheduled for neurosurgery
Criteria

Inclusion Criteria:

  • patient older than 18 years
  • patient scheduled for neurosurgery in prone position
  • patient equipped from an arterial catheter and stroke volume monitoring
  • Patient for whom volume expansion is needed.

Exclusion Criteria:

  • emergency surgery,
  • cardiac dysfunction,
  • arrythmia,
  • beta-blockade therapy,
  • pacemaker,
  • intracranial hypertension,
  • pregnancy,
  • dysautonomia

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): NCT04223414


Contacts
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Contact: Mathieu BIAIS, Pr 0557821019 ext +33 matthieu.biais@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Mathieu BIAIS, Pr    05 57 82 10 19    matthieu.biais@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04223414    
Other Study ID Numbers: CHUBX 2019/23
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
volume expansion
fluid responsiveness
stroke volume
perioperative optimization
analgesia nociception index
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases