Preoperative Dexamethasone Reduces Postoperative Pain, Nausea and Vomiting Following Mastectomy for Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pain was assessed immediately on return to the recovery room and at 6, 12 and 24 h after the operation using a visual analogue scale (VAS; 0 = no pain to 10 = most severe pain).
研究概览
简要总结
Postoperative pain, nausea and vomiting (PONV) are the most common complications after anesthesia and surgery. Women undergoing mastectomy with axillary dissection are at a particularly high risk for the development of PONV and an incidence of 60-80% in patients receiving no antiemetic has been reported. Emetic episodes predispose to aspiration of gastric contents, wound dehiscence, psychological distress, and delayed recovery and discharge times. These justify the use of prophylactic antiemetics in women scheduled for mastectomy. Most of the currently used antiemetics, including antihistamines, butyrophenones and dopamine receptor antagonists have been reported to cause occasional undesirable adverse effects, such as excessive sedation, hypotension, dry mouth, dysphoria, hallucinations and extrapyramidal signs. Antiserotonins (e.g., ondansetron) are available for the prevention and treatment of PONV in patients undergoing various types of surgery [4]. However, the use of prophylactic antiemetic therapy with antiserotonins has been criticized for being too expensive.
Dexamethasone was first reported to be an effective antiemetic regimen in patients receiving cancer chemotherapy.
The purpose of this study was to evaluate the efficacy of dexamethasone treatment for reducing pain and PONV as well as analgesic and antiemetic requirements in women undergoing general anesthesia for mastectomy with axillary lymph node dissection.
详细描述
Breast cancer is the most frequent malignant neoplasm worldwide. In emerging countries such as Mexico, there has been an increase in its frequency and mortality [1, 2] and it is the second most frequent neoplasm after cervical carcinoma. Between 25,000 and 30,000 new cases are diagnosed annually. Unfortunately, only a few women have regular mammography screening so the proportion of patients with locally advanced disease at diagnosis is high. In 2003, only 5-10% of newly diagnosed cases in Mexico were clinical stages 0 or I [2]. Surgical resection with axillary lymph node dissection constitutes the treatment of choice associated with neoadjuvant therapy and postoperative chemotherapy and/or radiation therapy.
Postoperative pain, nausea and vomiting (PONV) are the most common complications after anesthesia and surgery. Women undergoing mastectomy with axillary dissection are at a particularly high risk for the development of PONV and an incidence of 60-80% in patients receiving no antiemetic has been reported. Emetic episodes predispose to aspiration of gastric contents, wound dehiscence, psychological distress, and delayed recovery and discharge times. These justify the use of prophylactic antiemetics in women scheduled for mastectomy. Most of the currently used antiemetics, including antihistamines, butyrophenones and dopamine receptor antagonists have been reported to cause occasional undesirable adverse effects, such as excessive sedation, hypotension, dry mouth, dysphoria, hallucinations and extrapyramidal signs. Antiserotonins (e.g., ondansetron) are available for the prevention and treatment of PONV in patients undergoing various types of surgery. However, the use of prophylactic antiemetic therapy with antiserotonins has been criticized for being too expensive.
Dexamethasone was first reported to be an effective antiemetic regimen in patients receiving cancer chemotherapy. Some authors have reviewed the available randomized trials (1996-2001) regarding perioperative single-dose steroid administration and found that dexamethasone had antiemetic and analgesic effects in various types of operations. One ot this studies demostrated that intravenous dexamethasone at 4 mg was effective for the prevention of PONV following breast surgery but they could not demonstrate any difference in postoperative pain.
The purpose of this study was to evaluate the efficacy of dexamethasone treatment for reducing pain and PONV as well as analgesic and antiemetic requirements in women undergoing general anesthesia for mastectomy with axillary node dissection.
Patients and Methods Patients Between June and August 2009, 70 patients undergoing mastectomy with axillary dissection were studied in a prospective, randomized, double-blind clinical trial. Patients were randomized to receive intravenous dexamethasone (8 mg) or homologated placebo 60 minutes before skin incision, using an equal number of blinded envelopes. Patients of American Society of Anesthesiologists classes III and IV were excluded. Further exclusion criteria were age more than 80 years; pregnancy; active menstruation; treatment with steroids; severe diabetes mellitus (serum HbA1c > 8%); use of opioids, sedatives or any kind of analgesics less than one week before mastectomy, or a history of alcohol or drug abuse. Patients with any history of motion sickness and ⁄or previous PONV after any surgical procedure were excluded. All patients were admitted to the hospital one day before the operation and were followed from hospital admission until 30 days after the surgical procedure to detect any medical or surgical morbidity.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists classes I-II female patients with breast cancer scheduled for surgical treatment; mastectomy plus axillary node dissection.
排除标准
- •American Society of Anesthesiologists classes III and IV.
- •Age more than 80 years; pregnancy; active menstruation; treatment with steroids; severe diabetes mellitus (serum HbA1c > 8%); use of opioids, sedatives or any kind of analgesics less than one week before mastectomy, or a history of alcohol or drug abuse.
- •Patients with any history of motion sickness and or previous postoperative nausea and vomiting after any surgical procedure.
研究组 & 干预措施
Dexamethasone group
This group of patients received intravenous dexamethasone (8 mg) 60 minutes before skin incision.
干预措施: intravenous dexamethasone (Drug)
Placebo group
Patients of these group received homologated placebo 60 minutes before skin incision.
干预措施: Homologated placebo. (Drug)
结局指标
主要结局
Pain was assessed immediately on return to the recovery room and at 6, 12 and 24 h after the operation using a visual analogue scale (VAS; 0 = no pain to 10 = most severe pain).
时间窗: 24 hours
The pain intensity was recorded by a member of the team, blinded to the interventional manouver. A visual analogue scale for pain was used. The patient stablished the pain intensity and the researcher captured el number level. The information was obtained in the recovery room after the patient was monitorized and blood pressure and oxigen blood content values were normal. The information was obtained after 6, 12 and 24 hours after the surgical procedure.
次要结局
- The incidence of nausea and vomiting was recorded immediately on return to the recovery room and at 6, 12 and 24 h after the operation, using a three point ordinal scale (0 = none, 1 = nausea, 2 = retching, 3 = vomiting).(24 hours)
- Total dose of backup analgesic and antiemetic medication administrated to each patient(24 hours)
- Morbidity and mortality after mastectomy(30 days)
