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

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT02193412

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypovolemia Somatic Pain	Procedure: noxious stimulus Procedure: change in operating table slope: head-down tilt position Procedure: change in operating table slope: head-up tilt position	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 4, 2015

Actual Primary Completion Date :

Oct 3, 2017

Actual Study Completion Date :

Oct 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients noxious stimulus change in operating table slope: head-down tilt position change in operating table slope: head-up tilt position	Procedure: noxious stimulus standardized noxious stimulus with tetanic stimulation Procedure: change in operating table slope: head-down tilt position -30° Other Names: Trendelenburg position Procedure: change in operating table slope: head-up tilt position +30°

Arm

Intervention/Treatment

Experimental: patients

noxious stimulus change in operating table slope: head-down tilt position change in operating table slope: head-up tilt position

Procedure: noxious stimulus

standardized noxious stimulus with tetanic stimulation

Procedure: change in operating table slope: head-down tilt position

-30°

Other Names:

Trendelenburg position

Procedure: change in operating table slope: head-up tilt position

+30°

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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°

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Lille	Nord	France	59000

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator: Benoît Tavernier, Pr, Lille University Hospital
Study Chair: Délégation à la Recherche Clinique et à l'Innovation (DRC), Lille University Hospital