Evaluation of an Immersive Audiovisual Distraction Device Impact on Peroperative Opioid Consumption. A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Intraoperative Remifentanil dose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •Signed consent
- •Outpatient surgery eligibility
- •Patient covered by social security
排除标准
- •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
结局指标
主要结局
Intraoperative Remifentanil dose
时间窗: 1 hour
μg/kg/min
次要结局
- Preoperative pain measured with a numeric pain rating scale (NRS)(1 hour)
- Post operative anxiety measured by a visual analogue scale (VAS)(1 hour)
- Preoperative anxiety measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)(1 hour)
- Preoperative anxiety measured by a visual analogue scale (VAS)(1 hour)
- Per operative Analgesia nociception index (ANI) value(1 hour)
- Postoperative pain measured with a numeric pain rating scale (NRS)(1 hour)