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

NCT04223414 | Completed

• 1 other identifier: CHUBX 2019/23
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Volume Expansion; Fluid Responsiveness

Keywords

volume expansion; fluid responsiveness; stroke volume; perioperative optimization; analgesia nociception index

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Analgesia Nociception Index (ANI) DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient scheduled for neurosurgery

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

Related Publications (1)

• de Courson H, Chadefaux G, Abel B, Georges D, Verchere E, Biais M. Ability of the Analgesia Nociception Index variations to identify a response to a volume expansion of 250 mL of crystalloids in the operating room (REVANI): a prospective observational study. BMC Anesthesiol. 2023 Jun 21;23(1):218. doi: 10.1186/s12871-023-02181-2.

  PMID: 37344801 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 10, 2020
• Study Start: January 29, 2020
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)