Evaluation of Immersive Audiovisual Distraction Impact on Peroperative Opioid Consumption.

Not Applicable

Completed

• Conditions: Analgesia; Surgical Procedure, Unspecified; Outpatient
• Interventions: Device: Audiovisual distraction device; Device: Analgesia nociception index

• Registration Number: NCT04238572
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-23
• Study Start: 2020-02-19
• Status Verified: 2021-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Audiovisual distraction device	Audiovisual distraction device	Audiovisual distraction device, analgesia nociception index monitoring, remifentanil added to local anesthesia technique
Active comparator group	Analgesia nociception index	Analgesia nociception index monitoring, remifentanil added to local anesthesia technique
Audiovisual distraction device	Analgesia nociception index	Audiovisual distraction device, analgesia nociception index monitoring, remifentanil added to local anesthesia technique

Primary Outcome Measures

Name	Time	Method
Intraoperative Remifentanil dose	1 hour	μg/kg/min

Secondary Outcome Measures

Name	Time	Method
Post operative anxiety measured by a visual analogue scale (VAS)	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"
Preoperative pain measured with a numeric pain rating scale (NRS)	1 hour	Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable)
Preoperative anxiety measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)	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.
Preoperative anxiety measured by a visual analogue scale (VAS)	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"
Per operative Analgesia nociception index (ANI) value	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
Postoperative pain measured with a numeric pain rating scale (NRS)	1 hour	Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable)

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, Calvados, France