Evaluation of Immersive Audiovisual Distraction Impact on Peroperative Opioid Consumption.

Study Overview
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Brief Summary
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This study evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption for outpatient procedures with Remifentanil added to local anesthesia. Half of patients will receive an audiovisual distraction device while the other half not.

Detailed Description
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Early recovery for patients undergoing surgery is the key factor for an outpatient procedure. The technique of adding remifentanil to a local anesthesia is used in 22% of the procedures realized in The CHU de Caen Outpatient unit. Decreasing opioid dose, whose side effects are numerous and widely described, as well as reducing anxiety are daily challenges to ensure comfort and successful care. We propose a prospective, randomized, monocentric, open label study to evaluate the impact of the use of an audiovisual distraction device on the intraoperative consumption of opioids, on the patient's pain and peroperative anxiety. ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement. We will analyze if audiovisual distraction can integrate existing techniques such as hypnosis. Finally, we will also assess the medico-economic impact of this technique in order to establish a benefit / cost ratio.

Official Title
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Evaluation of an Immersive Audiovisual Distraction Device Impact on Peroperative Opioid Consumption. A Prospective Randomized Controlled Study

Conditions
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Surgical Procedure, Unspecified, Analgesia, Outpatient

Intervention / Treatment
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* Device: Audiovisual distraction device
* Device: Analgesia nociception index


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient Signed consent Outpatient surgery eligibility Patient covered by social security Exclusion Criteria: Unsigned consent Study participation refusal Deafness, blindness Claustrophobia ANI contraindication (atrial fibrillation, pace maker, severe autonomic system dysfunction) Contraindication or impossibility to use the audiovisual distraction device

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 200 patients will be randomized. 100 patients operated on in vitro fertilization (50 patients in intervention group, 50 patients in active comparator group) 100 patients operated on venous access port placement (50 patients in intervention group, 50 patients in active comparator group)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Audiovisual distraction device<br>Audiovisual distraction device, analgesia nociception index monitoring, remifentanil added to local anesthesia technique | Device: Audiovisual distraction device<br>* Evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption<br>Device: Analgesia nociception index<br>* ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement<br>|
| Active Comparator: Active comparator group<br>Analgesia nociception index monitoring, remifentanil added to local anesthesia technique | Device: Analgesia nociception index<br>* ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Remifentanil dose | μg/kg/min | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative pain measured with a numeric pain rating scale (NRS) | Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable) | 1 hour | 
| Preoperative anxiety measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) | APAIS measures the need-for-information with 6 items. Each one is rated from 1 = Not at all to 5 = Extremely. There is positive and significant correlation between the ned-for-information and anxiety. | 1 hour | 
| Preoperative anxiety measured by a visual analogue scale (VAS) | Visual analogue scale is a 100mm horizontal line. At the left hand (0mm) the statement not anxious at all and at the right hand (100mm) the statement most anxious I can imagine | 1 hour | 
| Per operative Analgesia nociception index (ANI) value | From 0 = Predominant sympathetic tone, pain and anxiety to 100 = Predominant parasympathetic tone, good analgesia. Negative linear Relationship between analgesia nociception index and pain scores | 1 hour | 
| Post operative anxiety measured by a visual analogue scale (VAS) | Visual analogue scale is a 100mm horizontal line. At the left hand (0mm) the statement not anxious at all and at the right hand (100mm) the statement most anxious I can imagine | 1 hour | 
| Postoperative pain measured with a numeric pain rating scale (NRS) | Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable) | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Audiovisual distraction device, Peroperative opioid analgesia, Ambulatory care, Outpatient, Analgesia nociception index, Anxiety, Remifentanil, Remifentanil added to local anesthesia