Clinical Trials Directory

Trials / Completed

CompletedNCT02193412

Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine whether the value of analgesia nociception index (ANI) is influenced by variations of systemic venous return (cardiac preload) under general anaesthesia.

Detailed description

In the context of opioid sparing goal during general anaesthesia, the Analgesia nociception index (ANI) is an analgesia/nociception balance monitoring tool computed from high frequency heart rate variability analysis, and developed by MetroDoloris (Lille, France). Its sensitivity to detect noxious stimulus was studied in several studies. However, its specificity is not established in particular in the presence of factors influencing autonomic nervous system other than analgesia/nociception balance. In the context of anaesthesia, one of the most relevant factor is hypovolemia. This study aims to assess the effect of blood volume variations on ANI under general anaesthesia, independently of analgesia/nociception balance status. Variations of systemic venous return (SVR) (cardiac preload), which reflects blood volume status, will be induced by changes of operating table slope, from head-down tilt (Trendelenburg), with increased SVR, to head-up tilt position, with decreased SVR. Variations of SVR will be attested by changes in the arterial pulse pressure variation, a well-established indice of preload responsiveness in the mechanically ventilated anaesthetized patient.

Conditions

Interventions

TypeNameDescription
PROCEDUREnoxious stimulusstandardized noxious stimulus with tetanic stimulation
PROCEDUREchange in operating table slope: head-down tilt position-30°
PROCEDUREchange in operating table slope: head-up tilt position+30°

Timeline

Start date
2015-01-04
Primary completion
2017-10-03
Completion
2017-10-03
First posted
2014-07-17
Last updated
2020-10-14

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02193412. Inclusion in this directory is not an endorsement.