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

Fluid Responsiveness Clinical Trial

— REVANI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223414
• Other study ID #: CHUBX 2019/23
• Status: Completed
• Start date: January 29, 2020
• Est. completion date: June 25, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 25, 2020
• Est. primary completion date: June 25, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fluid Responsiveness
• Stroke
• Volume Expansion

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ANI value variation (%) before and after the 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).	5 minutes after volume expansion