NCT04238572

Evaluation of Immersive Audiovisual Distraction Impact on Peroperative Opioid Consumption.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Procedure, Unspecified
• Analgesia
• Outpatient

Interventions

Type	Name	Description
DEVICE	Audiovisual distraction device	Evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption
DEVICE	Analgesia nociception index	ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement

Timeline

• Start date: 2020-02-19
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2020-01-23
• Last updated: 2021-08-03

Locations

1 site across 1 country: France