Clinical trial NCT04238572: Evaluation of Immersive Audiovisual Distraction Impact on Peroperative Opioid Consumption.
Official title: Evaluation of an Immersive Audiovisual Distraction Device Impact on Peroperative Opioid Consumption. A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Analgesia
Outpatient
Keywords: Audiovisual distraction device
Peroperative opioid analgesia
Ambulatory care
Outpatient
Analgesia nociception index
Anxiety
Remifentanil
Remifentanil added to local anesthesia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative Remifentanil dose
timeFrame: 1 hour
Secondary outcomes:
measure: Preoperative pain measured with a numeric pain rating scale (NRS)
timeFrame: 1 hour
measure: Preoperative anxiety measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: 1 hour
measure: Preoperative anxiety measured by a visual analogue scale (VAS)
timeFrame: 1 hour
measure: Per operative Analgesia nociception index (ANI) value
timeFrame: 1 hour
measure: Post operative anxiety measured by a visual analogue scale (VAS)
timeFrame: 1 hour
measure: Postoperative pain measured with a numeric pain rating scale (NRS)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Calvados
Study officials:
affiliation: Caen UH
name: Clément Buléon, MD
role: STUDY_CHAIR
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