Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- PONV within the first 24h after surgery
研究概览
简要总结
Breast cancer is one of the three most common cancers worldwide, and the primary treatment method is surgery.Since most patients are non-smokers who use opioids in the postoperative period, which are known risk factors for postoperative nausea and vomiting (PONV) according to the Apfel Risk Score. Breast surgery was identified as a strong risk factor for PONV. According to the previous studies, the incidence of PONV is 30-70% in patients undergoing the breast cancer surgery, which not only gives patients unpleasant and painful experience, but also prolongs the hospital stays and delay patient discharge and adds to hospital costs. We compared the effects of dexamethasone alone vs. in combination with Pericardium 6 (P6) electrical stimulation or granisetron for inhibition of PONV in women undergoing breast cancer surgery.
详细描述
186 patients who are planed to undergo elective breast cancer surgery under general anaesthesia into the following three groups: acupoint stimulation+dexamethasone (Group Acu, n=62), granisetron +dexamethasone (Group Gra, n=62), and dexamethasone alone (Group Dxm, n=62). The incidence of nausea, vomiting, and need for rescue antiemetics was recorded 2, 6, 24, and 48 h after surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women undergoing breast cancer resection under general anesthesia
- •aged between 18 to 65
- •American Society of Anesthesiologists grade I-II
排除标准
- •using antiemetic drugs within 24 h before operation,
- •nausea or vomiting within 24 h before operation;
- •Alcoholic or drug abuse,
- •abnormal liver and/or kidney function, diabetic or peripheral neuropathy patients, cardiovascular disease (excluding those with controlled hypertension).
- •refuse to participate clinical trial
研究组 & 干预措施
Group Acu
a surface electrode was applied in the induction room to the P6 acupoint on the dominant upper extremity, located ∼4 cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode on the opposing dorsal aspect of the forearm. When the patient enters the operating room， an investigator connected the device to both electrodes with electrical wires, set initial electric stimulating current at 1 mA with the frequency at 2 Hz(square-wave pulses of 0.2 ms), gradually increased the current intensity until the patient felt pain or reached the discomfort threshold (ranging from 6 to 20 mA), and maintained the stimulation until end of operation.
At the start of skin closure, saline (3 ml) was administered i.v.
干预措施: electric stimulation therapy (Device)
Group Gra
Group Gra receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control.
At the start of skin closure, granisetron (3 mg; Group Trp) was administered i.v.
干预措施: electric stimulation therapy (Device)
Group Dxm
Group Dxm receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control.
At the start of skin closure, saline (3 ml) was administered i.v.
干预措施: electric stimulation therapy (Device)
结局指标
主要结局
PONV within the first 24h after surgery
时间窗: 24 hours after surgery.
the incidence and severity of PONV
次要结局
- the use of postoperative antiemetics(48 hours after surgery)
- PONV within the first 48h after surgery(48 hours after surgery)
- postoperative pain score(3 months after surgery)