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

Primary Purpose

Hypovolemia, Somatic Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
noxious stimulus
change in operating table slope: head-down tilt position
change in operating table slope: head-up tilt position
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypovolemia focused on measuring analgesia nociception index, heart rate variability, autonomic nervous system, specificity, systemic venous return, pulse pressure variation, Intraoperative Monitoring

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients

Arm Description

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

Outcomes

Primary Outcome Measures

change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position
Position -20° to +20°

Secondary Outcome Measures

change in ANI between horizontal position and head-down/head up tilt position
Position 0° to -20° Position +20° to 0°
change in pulse pressure variation between head-down tilt position and head-up tilt position
Position -20° to +20°
change in ANI induced by standardized noxious stimulus (tetanic stimulation)
ANI measurement following tetanus
variations of low frequency variability of arterial blood pressure
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
Position 0° to -20° Position +20° to 0°

Full Information

First Posted
July 15, 2014
Last Updated
October 12, 2020
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02193412
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 4, 2015 (Actual)
Primary Completion Date
October 3, 2017 (Actual)
Study Completion Date
October 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia, Somatic Pain
Keywords
analgesia nociception index, heart rate variability, autonomic nervous system, specificity, systemic venous return, pulse pressure variation, Intraoperative Monitoring

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
noxious stimulus change in operating table slope: head-down tilt position change in operating table slope: head-up tilt position
Intervention Type
Procedure
Intervention Name(s)
noxious stimulus
Intervention Description
standardized noxious stimulus with tetanic stimulation
Intervention Type
Procedure
Intervention Name(s)
change in operating table slope: head-down tilt position
Other Intervention Name(s)
Trendelenburg position
Intervention Description
-30°
Intervention Type
Procedure
Intervention Name(s)
change in operating table slope: head-up tilt position
Intervention Description
+30°
Primary Outcome Measure Information:
Title
change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position
Description
Position -20° to +20°
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)
Secondary Outcome Measure Information:
Title
change in ANI between horizontal position and head-down/head up tilt position
Description
Position 0° to -20° Position +20° to 0°
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)
Title
change in pulse pressure variation between head-down tilt position and head-up tilt position
Description
Position -20° to +20°
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)
Title
change in ANI induced by standardized noxious stimulus (tetanic stimulation)
Description
ANI measurement following tetanus
Time Frame
during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)
Title
variations of low frequency variability of arterial blood pressure
Description
Position 0° to -20° Position -20° to +20° Position +20° to 0°
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)
Title
change in pulse pressure variation between horizontal position and head-down/head up tilt position
Description
Position 0° to -20° Position +20° to 0°
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît Tavernier, Pr
Organizational Affiliation
Lille University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Délégation à la Recherche Clinique et à l'Innovation (DRC)
Organizational Affiliation
Lille University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France

12. IPD Sharing Statement

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

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