Evaluation of Immersive Audiovisual Distraction Impact on Peroperative Opioid Consumption.

University Hospital, Caen200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Surgical Procedure, Unspecified Analgesia Outpatient

Interventions

Audiovisual distraction deviceDEVICE

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

Analgesia nociception indexDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Caen University Hospital

Caen, Calvados, France

Outcomes

Primary Outcomes

Intraoperative Remifentanil dose

μg/kg/min

Time frame: 1 hour

Secondary Outcomes

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

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

Time frame: 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.

Time frame: 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"

Time frame: 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

Time frame: 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"

Time frame: 1 hour

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

Data from ClinicalTrials.gov

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