ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Multicentre, Randomised, Double-Blind Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- The incidence and severity of PONV
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is particularly one of the most common complications after laparoscopic sleeve gastrectomy (LSG). It can lead to serious adverse events and delayed activity, and prolong the time of rehabilitation and discharge. 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 LSG. 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
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. All subjects were randomly assigned to the following two groups: ST36 acupoint injection group (bilateral ST36 acupoint injection with scopolamine); pharmacoprophylaxis group (bilateral ST36 injection with normal saline). 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 computer-generated randomization sequence (http://www.randomization.com). Patients, surgeons, care givers, anesthesiologists, nursing staff, and outcomes assessor, 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)
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-IV
- •Scheduled for elective bariatric surgery
- •Written informed consent was obtained
排除标准
- •Patients with contraindications for acupoint injection
- •Difficulty in communicating with patients
- •Allergic diathesis for drugs used in the study or serious illness (heart, lung, kidney, or liver, et. al)
- •Coagulation dysfunction
- •Pre-existing psychological or neurological disorder
- •Pre-use medicine before surgery that would interferenced objective assessment (including the use of opioids, antiemetics or glucocorticoids)
- •Gastroesophageal reflux disease
结局指标
主要结局
The incidence and severity of PONV
时间窗: At 12-24 hours after surgery
The incidence and severity of PONV after bariatric surgery
The usage of rescue antiemetic drugs
时间窗: During 3 months after bariatric surgery
Total usage of rescue antiemetic drugs after bariatric surgery
次要结局
- Postoperative hospitalization duration(2 weeks after surgery)
- Hamilton anxiety rating scale(Before surgery and at postoperative 3 months)
- Pittsburgh sleep quality index(Before surgery and at postoperative 3 months)
- 15-item Quality of Recovery(QoR-15)(Postoperative 24 hours)
- Postoperative pain(At 0-24 and 24-72 hours after surgery)
- Consumption of analgesics(During 3 months after bariatric surgery)
- Ambulation time(Postoperative 1-3 days)
- Postoperative food and water intake time(Postoperative 1-3 days)
- Gastrointestinal Symptom Rating Scale(Before surgery and at postoperative 3 months)
- Hamilton depression rating scale(Before surgery and at postoperative 3 months)
- The MOS item short from health survey ,SF-36(Before surgery and at the postoperative 3 months.The scale consists of 36 items，divided into 8 sections，score of each section ranges from 0 to 100, the higher the score is, the healthier is.)
研究者
hui hou
Principal Investigator
The Second Hospital of Anhui Medical University