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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02193412

Enrollment

Registered

2014-07-17

Start date

2015-01-04

Completion date

2017-10-03

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovolemia, Somatic Pain

Keywords

analgesia nociception index, heart rate variability, autonomic nervous system, specificity, systemic venous return, pulse pressure variation, Intraoperative Monitoring

Brief 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.

Interventions

PROCEDUREnoxious stimulus

standardized 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°

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position	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

Measure	Time frame	Description
change in ANI between horizontal position and head-down/head up tilt position	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°
change in pulse pressure variation between head-down tilt position and head-up tilt position	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°
change in ANI induced by standardized noxious stimulus (tetanic stimulation)	during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)	ANI measurement following tetanus
variations of low frequency variability of arterial blood pressure	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°
change in pulse pressure variation between horizontal position and head-down/head up tilt position	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°

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBenoît Tavernier, Pr

University Hospital, Lille

STUDY_CHAIRDélégation à la Recherche Clinique et à l'Innovation (DRC)