Prediction of Pre-operative Anxiety by Heart Variability and Pupillometry

Study Overview
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Brief Summary
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The purpose of this study is to determine whether heart rate variability levels and pupillometric measures are effective objective predictors of anxiety among patients before surgery.

Detailed Description
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The prevalence of preoperative anxiety in adults is estimated between 60 and 80% and prevents a good integration of the information delivered, while seeking more attention from caregivers. In addition, anxious patients require the administration of higher doses of hypnotics at anesthetic induction. The pain expressed in the postoperative period is proportional to preoperative anxiety, with a slower recovery kinetics responsible for prolonged stay in the recovery room. Finally, the incidence of chronic pain is correlated with the intensity of preoperative anxiety. While the recommendations of the European Anesthesia Society (ESA) emphasize the importance of managing preoperative anxiety, this dimension is often overlooked and existing methods of assessment are time consuming and sometime inaccurate. Objective screening with dynamic monitoring of the level of anxiety in real time is the necessary step to ensure accurate detection and personalized management of the emotional state of patients before performing an invasive procedure. Anxiety is an emotional state reflecting an imbalance of cortico-frontal regulation on the limbic system. The interaction between these two neuronal systems is expressed in particular by the intensity of the vagal tone and the autonomic nervous system. Exploring the balance between sympathetic and parasympathetic systems is a promising avenue of exploration for identifying, predicting, and treating anxiety. Two reliable and easy-to-use devices analyzing the expression of the autonomic nervous system validated in the analysis of nociception in the awake patient or under general anesthesia are marketed: A. Analgesia Nociception Index (ANI) (MDoloris Medical Systems) analyzing oscillatory changes in heart rate as a function of respiratory time, namely the heart rate variability (HRV) B. Algiscan (IDMed) analyzing pupil responsiveness to nociception The use of these devices in conscious pre-operative patients could allow a reliable and objective detection of anxiety while following its kinetic evolution over time. The purpose of this project is to evaluate the validity of these two devices in the context of preoperative anxiety. After receiving clear information and giving their written agreement, patients will be included in the study by the anesthetist physician. During the anesthesia consultation, the included patients will be subjected to a Surgical Fear Questionnaire (SFQ) questionnaire of level of anxiety. A secondary study will consist of connecting a lighting device connected to the heart rate variability to emit a relaxing light in the preoperative waiting room.

Official Title
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Prospective Observational Study of the Non Invasive Objective Assessment of Pre-operative Anxiety Using the Heart Rate Variability and the Pupillary Reflex Measurement

Conditions
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Eligible for Day Case Surgery

Intervention / Treatment
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* Other: Analgesia Nociception Index
* Other: algiscan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Day case surgical patients Exclusion Criteria: <18yo psychiatric disorders participating refusal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Analgesia Nociception Index|Non invasive finger tip monitoring before during and 5 minutes after cannulation|
|Other: algiscan|Portable videopupillometer to measure pupillary light reflex (PLR), variation coefficient of pupillary diameter (VCPD), pupillary diameter (PD) fluctuations before, during and 5 minutes after cannulation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia Nociception Index (ANI) | Index from 0 to 100 Variation 5 minutes before during and 5 minutes after cannulation Comparison between anxious and non-anxious patients Measure of anxiety reduction | at Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of variation of pupillary diameter (CVDP) | Percentage from 0 to 100% Variation 5 minutes before during and 5 minutes after cannulation Comparison between anxious and non-anxious patients | at Day 0 | 
| Visual Analog Scale (VAS) | Measure of anxiety reduction 30 minutes after the beginnig of the luminous immersion | at Day 0 | 
| Heart rate variability | comparison between anxious and non-anxious patients Variation 5 minutes before during and 5 minutes after cannulation | at Day 0 | 
| Analgesia Nociception Index (ANI) | Impact of 30 minutes immersive light intervention on measures of ANI and VAE | at Day 0 - after 30 minutes immersive light intervention | 
| Visual Analog Scale (VAS) | Impact of 30 minutes immersive light intervention on measures of ANI and VAS | at Day 0 - after 30 minutes immersive light intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-operative anxiety, pupillometry, heart rate variability, cardiac coherence state, ambulatory surgery