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Completed

NCT Number: NCT04238572

Evaluation of Immersive Audiovisual Distraction Impact on Peroperative Opioid Consumption.

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.

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Key information

Conditions

Surgical Procedure, Unspecified Agnosia Analgesia Anxiety Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Outpatient Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, Calvados, 14000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audiovisual distraction device

Device

Evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption

Analgesia Nociception Index

Device

ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement

Primary outcomes

  1. Intraoperative Remifentanil dose

    Time frame: 1 hour

    μg/kg/min

Secondary outcomes

  1. Preoperative pain measured with a numeric pain rating scale (NRS)

    Time frame: 1 hour

    Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable)

  2. Preoperative anxiety measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Time frame: 1 hour

    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.

  3. Preoperative anxiety measured by a visual analogue scale (VAS)

    Time frame: 1 hour

    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"

  4. Per operative Analgesia nociception index (ANI) value

    Time frame: 1 hour

    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

  5. Post operative anxiety measured by a visual analogue scale (VAS)

    Time frame: 1 hour

    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"

  6. Postoperative pain measured with a numeric pain rating scale (NRS)

    Time frame: 1 hour

    Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable)

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: AmbuCineView

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2020
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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