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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-04

Study Completion Date

2017-10-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypovolemia Somatic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients

1. noxious stimulus
2. change in operating table slope: head-down tilt position
3. change in operating table slope: head-up tilt position

Group Type EXPERIMENTAL

noxious stimulus

Intervention Type PROCEDURE

standardized noxious stimulus with tetanic stimulation

change in operating table slope: head-down tilt position

Intervention Type PROCEDURE

-30°

change in operating table slope: head-up tilt position

Intervention Type PROCEDURE

+30°

Interventions

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noxious stimulus

standardized noxious stimulus with tetanic stimulation

Intervention Type PROCEDURE

change in operating table slope: head-down tilt position

-30°

Intervention Type PROCEDURE

change in operating table slope: head-up tilt position

+30°

Intervention Type PROCEDURE

Other Intervention Names

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Trendelenburg position

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No