Skip to main content
OpenTrials
Completed

NCT Number: NCT02193412

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Lille, Nord, 59000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • neurosurgical operation requiring invasive monitoring of arterial blood pressure

Exclusion criteria

  • pacemaker, arrhythmia
  • chronic medication with beta blocker
  • possible disorder of autonomic nervous system: diabetes, alcoholism, chronic pain
  • anticholinergic drug administration before measures
  • intracranial hypertension
  • no social security coverage
  • pregnancy

Treatment and study plan

noxious stimulus

Procedure

standardized noxious stimulus with tetanic stimulation

change in operating table slope: head-down tilt position

Procedure

-30°

Other names: Trendelenburg position

change in operating table slope: head-up tilt position

Procedure

+30°

Primary outcomes

  1. change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position

    Time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

    Position -20° to +20°

Secondary outcomes

  1. change in ANI between horizontal position and head-down/head up tilt position

    Time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

    Position 0° to -20° Position +20° to 0°

  2. change in pulse pressure variation between head-down tilt position and head-up tilt position

    Time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

    Position -20° to +20°

  3. change in ANI induced by standardized noxious stimulus (tetanic stimulation)

    Time frame: during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)

    ANI measurement following tetanus

  4. variations of low frequency variability of arterial blood pressure

    Time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

    Position 0° to -20° Position -20° to +20° Position +20° to 0°

  5. change in pulse pressure variation between horizontal position and head-down/head up tilt position

    Time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

    Position 0° to -20° Position +20° to 0°

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2014
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.