Evaluation of Immersive Audiovisual Distraction Impact on Peroperative Opioid Consumption. (AmbuCineView)

Caen University Hospital

Status: Completed

Conditions: Surgical Procedure, Unspecified; Analgesia; Outpatient

Treatments: Device: Analgesia nociception index; Device: Audiovisual distraction device

Study type: Interventional

Funder types: Other

Identifiers

NCT04238572

2019-A01243-54

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Audiovisual distraction device

Experimental group

Description:

Audiovisual distraction device, analgesia nociception index monitoring, remifentanil added to local anesthesia technique

Treatment:

Device: Audiovisual distraction device

Device: Analgesia nociception index

Active comparator group

Active Comparator group

Description:

Analgesia nociception index monitoring, remifentanil added to local anesthesia technique

Treatment:

Device: Analgesia nociception index