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

August 2, 2021 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Calvados
      • Caen, Calvados, France, 14000
        • CAEN university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Audiovisual distraction device
Audiovisual distraction device, analgesia nociception index monitoring, remifentanil added to local anesthesia technique
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
ACTIVE_COMPARATOR: Active comparator group
Analgesia nociception index monitoring, remifentanil added to local anesthesia technique
Device: Analgesia nociception index
ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Remifentanil dose
Time Frame: 1 hour
μg/kg/min
1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Study Chair: Clément Buléon, MD, Caen UH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 19, 2020

Primary Completion (ACTUAL)

January 1, 2021

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (ACTUAL)

January 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-A01243-54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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