Randomized Clinical Trial to Evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting (PONV) in Ambulatory Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Percentage of patients with a score <50 on the PONV Intensity Scale at 72 hours postoperatively.
研究概览
简要总结
To evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting (PONV) in Ambulatory Surgery.
详细描述
Prospective, randomized, comparative study.
The disease to be studied is Postoperative Nausea and Vomiting (PONV). PONV, described by some as "The Big Little Problem", has a great impact on patient´s satisfaction and the postoperative care needed. Considering the increase of outpatient surgery there is an expanding demand for effective PONV treatment to prevent delays in discharge or unplanned readmissions. The estimated annual costs of PONV in the U.S. per year are 100 million Dollars.
Approximately 75 million patients are anesthetized in the world annually. It is estimated that 20-30% of these patients experience PONV, reaching 80% in patients at high risk. This incidence of PONV has maintained despite the improvement in surgical and anesthetic techniques and advances in antiemetic pharmacology. Increasingly, acupuncture is becoming part of Western medicine as a complementary treatment. Acupuncture has been described to effectively reduce the symptoms of different diseases, including PONV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes, aged 18 years and older.
- •ASA I-II patients who will undergo a surgical procedure under general anesthesia in an ambulatory setting.
- •Patients who are anticipated to not require admission to the recovery room or intensive care unit.
- •Patients who, according to clinical criteria of the acupuncturist physician, are likely to benefit from acupuncture.
- •Patients with a sufficient educational level to complete the health questionnaires required in the study.
- •Patients who have given their written informed consent to participate in the study.
排除标准
- •Patients with any pathology that under medical discretion makes their participation in the study inadvisable.
- •Patients who cannot respond to the questionnaires provided during the study.
- •Patients with known hypersensitivity to the materials of the ear seeds.
结局指标
主要结局
Percentage of patients with a score <50 on the PONV Intensity Scale at 72 hours postoperatively.
时间窗: 72 hours
The percentage of patients with a score \<50 on the PONV Intensity Scale (defined as clinically not significant PONV) at 72 hours postoperatively will be assessed in the experimental and control group, respectively. In the experimental group, patients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25. In the control (placebo) group, patients receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3.
次要结局
- Assessment of costs and economic impact of the disease(72 hours)
- Assessment of need for rescue antiemetic medication(72 hours)
- Percentage of patients with a score <50 on the PONV Intensity Scale at 6 and 24 hours postoperatively.(6 and 24 hours)
- Evaluation of the postoperative recovery outcome(24 hours)
- Evaluation of perioperative pain(72 hours)
- Assessment of the patient´s satisfaction with the perioperative care(72 hours)