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.

Study Overview

• Status: Completed
• Conditions: Hypovolemia; Somatic Pain
• Intervention / Treatment: Procedure: noxious stimulus; Procedure: change in operating table slope: head-down tilt position; Procedure: change in operating table slope: head-up tilt position

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nord
    • Lille, Nord, France, 59000
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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°

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position	Position -20° to +20°	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in ANI between horizontal position and head-down/head up tilt position	Position 0° to -20° Position +20° to 0°	during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
change in pulse pressure variation between head-down tilt position and head-up tilt position	Position -20° to +20°	during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
change in ANI induced by standardized noxious stimulus (tetanic stimulation)	ANI measurement following tetanus	during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)
variations of low frequency variability of arterial blood pressure	Position 0° to -20° Position -20° to +20° Position +20° to 0°	during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
change in pulse pressure variation between horizontal position and head-down/head up tilt position	Position 0° to -20° Position +20° to 0°	during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2015
• Primary Completion (Actual): October 3, 2017
• Study Completion (Actual): October 3, 2017

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: autonomic nervous system; pulse pressure variation; heart rate variability; specificity; analgesia nociception index; systemic venous return; Intraoperative Monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Hypovolemia; Nociceptive Pain
• Other Study ID Numbers: 2013_13; 2013-A01645-40 (Other Identifier: ID-RCB number,ANSM)