The Effect of Intravenous Lidocaine on Propofol Requirements in Patients Undergoing Hysteroscopy and Diagnostic Curettage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Propofol Requirements
研究概览
简要总结
Lidocaine, an amide local anesthetic, has advantages of low price and easily obtaining. Intravenous lidocaine (IVL)initially has been used in the treatment of arrhythmia. It was demonstrated that IVL had analgesic effect, especially in colorectal surgery, but remained controversy in other types of surgeries. Other beneficial effects, such as prevention of hyperalgesia and propofol-induced injection pain, reduction of incidence of postoperative ileus and nausea and vomiting and anti-inflammatory also were proposed.
详细描述
The most frequent drugs for procedural sedation and analgesia are propofol, benzodiazepines and opioids. However, these drugs may cause respiratory depression and circulatory instability. Combination will increase the risk of hypoxia and apnea.
In China, most anesthesia for hysteroscopy and gastroenteroscopy is procedural sedation and analgesia(PAS) provided by anesthetists. Foester et,al. have been tested that IVL could significantly reduce propofol requirements 、postoperative pain and fatigue scores in colonoscopy. Chen,et,al. find the same effect of IVL in elderly. However, there is no research reporting IVL used in hysteroscopy and diagnostic curettage. So, our main objective is to evaluate the effect of intravenous lidocaine on propofol requirements in patients undergoing hysteroscopy and diagnostic curettage.
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, Investigator)
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
- •Patients who underwent hysteroscopy and diagnostic curettage, American Society of Anesthesiologist' physical status 1-2, BMI 18.5-24.9 kg/m2,
排除标准
- •Patients with known allergy to lidocaine or other local anesthetics, taken sedatives and analgesics within 1 week before surgery, mental and neurological diseases, hearing impairment, unwilling to sign informed consent or participate in the study, serious arrhythmia and organic heart disease.
研究组 & 干预措施
Group Lidocaine
20 eligible patients are received 1.5mg/kg 1%lidocaine intravenously over 30-60s. Then, 4mg/kg/h lidocaine infused intravenously until end of procedure.
干预措施: Lidocaine IV (Drug)
Group Control
2020 eligible patients are received equal 0.9% normal saline.
干预措施: 0.9% normal saline (Drug)
结局指标
主要结局
Propofol Requirements
时间窗: from loss of conciousness to end of procedure
propofol requirements at loss of conciousness and supplemental requirements during procedure
次要结局
- Pain score(immediately, 15 min, 30 min in PACU)
- Fatigue score(immediately, 15 min, 30 min in PACU)