The Effect of Intravenous Magnesium Sulfate on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- The incidence of PONV
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is commonly accompanied in patients undergoing surgery under general anesthesia. The patients undergoing laparoscopic gynecologic surgery have multiple risk factors for developing PONV such as female gender, nonsmoker, postoperative opioids, and laparoscopic surgery. Thus, it is important to prevent PONV in these patients.
详细描述
Magnesium is a N-methyl-D-aspartate (NMDA) antagonist that is known to be effective in reducing opioid consumption and controlling postoperative pain. This opioid reducing effect can be associated with reduction of the incidence of PONV. However, the effect of magnesium on preventing PONV have not been investigated before. Thus, the investigators hypothesized that intraoperative infusion of magnesium will be effective in preventing PONV in patients undergoing laparoscopic gynecologic 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gynecologic disease
- •Female patients undergoing laparoscopic gynecologic surgery and receiving postoperative fentanyl based intravenous patient controlled analgesia (PCA), aged 20-65 years.
排除标准
- •impaired renal or hepatic function (Glutamic Oxalacetate Transaminase [GOT]/Glutamic Pyruvate Transaminase [GPT]>50, estimated glomerular filtration rate [eGFR]<60)
- •atrioventricular block, myopathies, diabetes, treated with calcium channel blockers
- •History of receiving antiemetics within 1 day before surgery
- •History of receiving opioids or non-steroidal anti-inflammatory drugs within 1 week of surgery
- •drugs or alcohol abuse
- •patients treated with isoniazid, chlorpromazine, or digoxin
- •patients who cannot communicated with others or with cognitive dysfunction
- •patients who cannot read informed consent
研究组 & 干预措施
Mg group
20mg/kg of magnesium sulfate will be infused after induction of anesthesia. And magnesium sulfated will be continuously infused at a rate of 15mg/kg/h during the operation.
干预措施: Mg (magnesium sulfate) (Drug)
Control group
Same volume of normal saline will be infused after induction of anesthesia. And the same volume of normal saline will be continuously infused at a same rate of magnesium during the operation.
干预措施: Control (saline) (Drug)
结局指标
主要结局
The incidence of PONV
时间窗: up to postoperative 2 days
The incidence of PONV will be measured up to postoperative 2 days.
次要结局
未报告次要终点
研究者
Do-Hyeong Kim
Department of Anesthesiology and Pain Medicine, Assistant Professor
Gangnam Severance Hospital