Effect of Intravenous Lidocaine Combined With Dexmedetomidine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- postoperative nausea
研究概览
简要总结
BACKGROUND: Few researches have manifested that intravenous (IV) lidocaine or dexmedetomidine decreased the incidence of postoperative nausea and vomiting (PONV). The investigators investigated whether IV lidocaine plus dexmedetomidine infusion could better reduce the incidence of PONV after laparoscopic hysterectomy.
METHODS: One hundred and twenty women with elective laparoscopic hysterectomy were randomly divided into two groups: patients in the lidocaine combined with dexmedetomidine group (LD group, n=60) received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine (0.5 μg/kg loading, 0.4 μg/kg/h infusion) respectively. Patients in the control group (CON group, n=60) received the equal volume of saline. Primary outcome was the incidence of the first 48 h nausea, vomiting and PONV after surgery. The secondary outcomes included perioperative propofol and remifentanil consumption, postoperative fentanyl requirement, Ramsay sedation score, and bradycardia during post-anaesthesia care unit (PACU) stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
- •Aged 40-55 years
- •Scheduled for elective laparoscopic hysterectomy
排除标准
- •History of allergy to local anesthetics
- •Severe respiratory disease
- •Renal or hepatic insufficiency
- •History of preoperative opioids medication and psychiatric
- •preoperative bradycardia
- •preoperative atrioventricular block
- •Subjects who experienced severe hypotension (mean arterial pressure [MAP] <60 mmHg) or bradycardia (heart rate [HR] <40 bpm), urticaria, or arrhythmia during lidocaine and dexmedetomidine infusion period
研究组 & 干预措施
Effect of IV lidocaine and dexmedetomidine on PONV
干预措施: lidocaine and dexmedetomidine IV (Drug)
Effect of IV lidocaine and dexmedetomidine on PONV
干预措施: saline IV (Drug)
Effect of IV saline on PONV
干预措施: lidocaine and dexmedetomidine IV (Drug)
Effect of IV saline on PONV
干预措施: saline IV (Drug)
结局指标
主要结局
postoperative nausea
时间窗: 24-48 hours after surgery
Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
postoperative vomiting
时间窗: 24-48 hours after surgery
Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery
postoperative nausea and vomiting (PONV)
时间窗: 24-48 hours after surgery
Our primary outcome was the incidence of PONV during the 24-48 hours after surgery
次要结局
未报告次要终点
研究者
Xu Siqi
Department of Anesthesiology
Anqing Municipal Hospital