Acupuncture for Enhancing Recovery and Attenuating Postoperative Nausea and Vomiting After Middle Ear Surgeries: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- incidence of postoperative nausea and vomiting
研究概览
简要总结
Modern surgery management needs increasing operating room turnover and more ambulatory surgery. In order to come over this challenge, the recovery needs to be optimized. Enhancing recovery could be achieved by preventing postoperative pain and postoperative nausea and vomiting. Middle ear surgery is a common ambulatory surgery with increasing occurrence of postoperative nausea and vomiting.
详细描述
Sample size: as percent of vomiting following acupuncture and following standard anesthesia is 0.13% and 29.2% respectively so sample size is 58 (29 in each group). Sample is calculated using open epi program with confidence level 95% and power 80%.
Patients in Group C (control group) (n=29): will receive no treatment. While patients in Group A (Acupuncture group) (n=29): will receive needle acupuncture.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent from the patient.
- •Age: 21-60 years old.
- •Sex: both sex (males or females).
- •Physical status: ASA 1& II.
- •BMI = (20-30 kg/m2).
- •Type of operations: elective unilateral middle ear surgeries such as tempanoplasty, stapedectomy and mastedictomy.
排除标准
- •Altered mental state
- •Patients with Drug abuse or alcohol.
- •Patients with on antipsychotic drugs, regular antiemetic therapy or receiving antiemetic 24 hour before surgery.
- •Patients with pre-treatment with acupuncture or trigger point injection.
- •Pregnancy.
结局指标
主要结局
incidence of postoperative nausea and vomiting
时间窗: up to 24 hours postoperative
Postoperative nausea and vomiting impact scale score . Questions Answers score Did you have vomiting or dry retching? No 0 Once 1 Twice 2 Three or more times 3 Have you experienced a feeling of nausea? If yes, has it interfered with your daily activities? Not at all 0 Sometimes 1 Often/most of the times 2 All the time 3 Summation of numerical answer to question 1 plus 2 equal the PONV impact scale. PONV Impact Scale Score of ≥5 represents clinically important PONV
次要结局
- recovery time(up to 30 minutes postoperative)
- The total number of rescue antiemetic (metoclopramide)(in the first 24 hour postoperative)
- Postoperative Pain(up to 30 minutes, 2 hours and 4 hours postoperative)
- number of participant with side effects of acupuncture(up to 24 hours postoperative)
- The time of discharge(up to 30 minutes postoperative)
- extubation time(up to 10 minutes postoperative)
研究者
Marwa Mahmoud Abd Allah Zakzouk
Lecturer of Anesthesia & Surgical Intensive Care, Zagazig University
Zagazig University