Clinical trial NCT02193412: Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia
Official title: Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypovolemia
Somatic Pain
Keywords: analgesia nociception index
heart rate variability
autonomic nervous system
specificity
systemic venous return
pulse pressure variation
Intraoperative Monitoring
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position
timeFrame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
Secondary outcomes:
measure: change in ANI between horizontal position and head-down/head up tilt position
timeFrame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
measure: change in pulse pressure variation between head-down tilt position and head-up tilt position
timeFrame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
measure: change in ANI induced by standardized noxious stimulus (tetanic stimulation)
timeFrame: during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)
measure: variations of low frequency variability of arterial blood pressure
timeFrame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
measure: change in pulse pressure variation between horizontal position and head-down/head up tilt position
timeFrame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital
state: Nord
Study officials:
affiliation: Lille University Hospital
name: Benoît Tavernier, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Lille University Hospital
name: Délégation à la Recherche Clinique et à l'Innovation (DRC)
role: STUDY_CHAIR
References: