Use of Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery, With or Without Adenoids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Evaluating the effectiveness of intravenous lidocaine during anesthesia to decrease the numbers of events (vomiting) during the immediate postoperative period up to 24 hours postoperatively, comparing to placebo
研究概览
简要总结
There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults.
详细描述
The investigators want to know whether with intravenous lidocaine a adjunct for general anesthesia for children between 2 and 12 years who are undergoing tonsillectomy, with or without adenoids has the same effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 2 and 12 years
- •ASA I or II
- •Programmed for elective tonsillectomy with or without adenoidectomy under general anesthesia
排除标准
- •Obesity, defined as body mass index (BMI) ≥ 95th percentile for age and sex.
- •Use of antiemetic drugs during the 24 hours before surgery.
- •Gastroesophageal reflux.
- •History of allergy to any of the drugs used in the study.
- •Down Syndrome.
研究组 & 干预措施
Group L
Group L Lidocaine load dose 1.5 mg / kg over 5 minutes, followed by continuous infusion of 2 mg / kg / h, which is maintained until the end of surgical procedure
干预措施: Lidocaine (Drug)
Group P
Normal saline solution administered under the same regimen
干预措施: Normal saline (Drug)
结局指标
主要结局
Evaluating the effectiveness of intravenous lidocaine during anesthesia to decrease the numbers of events (vomiting) during the immediate postoperative period up to 24 hours postoperatively, comparing to placebo
时间窗: 24 hours
次要结局
- PACU opioid consumption(24 hours)
- Length of stay in PACU unit(24 hours)
- Compare frequency of vomiting by baseline risk(24 hours)
- Time at which discharge criteria are met Postanesthesia care unit (PACU)(24 hours)
- Time to first emetic drug administered(24 hours)
- Analysis of cost-effectiveness.(24 hours)
- The prevention of the composite "nausea / or vomiting"(24 hours)
- Time to first vomiting(24 hours)
- Postoperative pain using Children and Infants Postoperative Pain Scale , face or Visual analogue Scale, as appropriate(24 hours)
- Postoperative agitation using Pediatric Anesthesia Emergence Delirium Scale(24 hours)
- Type and number of doses of antiemetic drug required during hospitalization(24 hours)
- Total length of stay(24 hours)