Zusanli (ST36) Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Single-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The incidence of PONV within the first 24 hours
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is particularly distressing although it is not a fatal postoperative complication. Numbers of studies have been focused on identifying risk factors and therapies of PONV. Unfortunately, there' no consistent comments for PONV prevention in women after laparoscopic sleeve gastrectomy. Notably, Zusanli (ST36) acupoint and anisodamine have been evidenced to treat various gastrointestinal conditions. The primary outcome of this study was to evaluate the impact of anisodamine injection in ST36 on PONV in women following bariatric surgery.
详细描述
Acupuncture has been used as a medical technique in China for at least 2,000 years. More recently, it's also been extensively used in managing headache, chronic back pain, and PONV in USA. ST36 acupuncture is reported to be an effective preventive treatment for postoperative nausea and vomiting (PONV). However, It is not clear if it could efficiently prevent PONV in female patient who has underwent bariatric surgery. At the onset of this investigation, we have already identified several methodologic issues, such as the timing of the acupuncture intervention, sample size, perioperative anesthetic techniques, and appropriate control groups. The primary outcome of this study was the total incidence of PONV during the hospital and after the discharge. Participants were randomly assigned into different groups according to the with a computer-generated randomization sequence (http://www.randomization.com). Patients, surgeons, anesthesiologists, nursing staff, and the research assistant, were all blinded to the group assignment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Outcomes will be evaluated by anesthesiologists who are blinded to the treatment allocation. Patients, investigators and observers will be blinded to the patient allocation throughout the entire study period.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with an American Society of Anesthesia (ASA) physical status Ⅰ-Ⅲ
- •Scheduled for elective bariatric surgery .
排除标准
- •lack of patient consent
- •patients with contraindications for acupoint injection
- •obesity due to endocrine disorder
- •allergic diathesis for drugs used in the study
- •serious illness (heart, lung, kidney, or liver)
- •coagulation dysfunction
- •pre-existing psychological disorder
- •anticathartic , glucocorticoid or opiates medications
结局指标
主要结局
The incidence of PONV within the first 24 hours
时间窗: At 0-24 hours after surgery
The incidence of PONV within the first 24 hours
次要结局
- Postoperative hospitalization(During hospital)
- Time to the first rescue antiemetics(At 0-24 hours after surgery)
- Consumption of propofol(During the surgery)
- Length of anesthesia(At the end of anesthesia)
- Length of surgery(At the end of surgery)
- Adverse events(Within 3 months after surgery)
- Pittsburgh Sleep Quality Index(Before surgery and at the postoperative 3 months)
- The incidence and severity of PONV assessed at 2, 6, 48, and 72 hours after surgery(At 0-24 hours after surgery)
- Early recovery outcomes(Before discharge)
- Consumption of remifentanil(During the surgery)
- Consumption of cisatracurium(During the surgery)
- Consumption of dexmedetomidine(During the surgery)
- QoR-15(At 24 hours after surgery)
- The usage of rescue antiemetic drugs(Within 24 hours after surgery in anesthesia resuscitation unit)
- BMI(Before surgery and at the postoperative 3 months)
- Gastrointestinal Symptom Rating Scale(Before surgery and at the postoperative 3 months)
- Hamilton Depression Rating Scale(Before surgery and at the postoperative 3 months)
- Hamilton Anxiety Rating Scale(Before surgery and at the postoperative 3 months)
研究者
hui hou
Principal Investigator
The Second Hospital of Anhui Medical University