Surgical Procedure, Unspecified, Analgesia, Outpatient
Conditions
Keywords
Audiovisual distraction device, Peroperative opioid analgesia, Ambulatory care, Outpatient, Analgesia nociception index, Anxiety, Remifentanil, Remifentanil added to local anesthesia
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.
Interventions
DEVICEAudiovisual distraction device
Evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption
ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Remifentanil dose | 1 hour | μg/kg/min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Preoperative pain measured with a numeric pain rating scale (NRS) | 1 hour | Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable) |
| 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 |
| Postoperative pain measured with a numeric pain rating scale (NRS) | 1 hour | Numeric pain rating scale (0 = No pain to 10 = Worst pain imaginable) |
| 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 |
Countries
France
Outcome results
None listed