The Effects of Gabapentin Premedication on Postoperative Pain,Nausea,Vomiting and Sedation in Patients Undergoing Neurosurgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Premedication gabapentin can decrease pain in early postoperative period
研究概览
简要总结
The study is to observe the effects of gabapentin premedication on postoperative pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are randomized into groups gabapentin(GG) or placebo(GP). Patients are given gabapentin or placebo orally the night before operation day and 2hours before surgery,respectively.The investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be observed in GG than GP.
详细描述
This is a random, double-blind study. In GG, patients are given gabapentin 600mg orally at the night and 2hours before surgery, respectively. In PG, vitamine pills are given instead.Total intravenous anesthesia is applied for all patients. 1hour, 2hours,1day, 2days, 3months and 6months after surgery, patients are evaluated for pain (VAS) and incidence of PONV. In addition,Glasgow Score, Ramsay Score and other gabapentin-related effects, such as somnolence,dizzy or dry mouth are also observed.The incidence of persistent pain and neuropathic pain was assessed at the 3-mo and 6-mo postoperative evaluation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old, ASA physical status I or II, BMI<30
- •Scheduled for elective craniotomy
- •Cooperative and given informed consent in person
排除标准
- •History of mental or psychiatric disorders
- •Pregnant or lactating female
- •History of systemic malignant tumor or diabetes
- •Previously treated with this protocol or participated in another experimental study within previous 30 days
- •Suspected history of allergic reaction or intolerance to gabapentin or other anesthetic agents in this study
- •History of alcohol abuse and/or drug abuse within previous one year
研究组 & 干预措施
vitamin capsules
vitamin capsules orally at the night before operation and 2 hours before surgery,respectively
干预措施: vitamin capsules (Drug)
gabapentin
gabapentin 600mg orally at the night before operation and 2 hours before surgery,respectively
干预措施: gabapentin (Drug)
结局指标
主要结局
Premedication gabapentin can decrease pain in early postoperative period
时间窗: 24 hour after extubation
postoperative pain scores(Visual Analogue Scale)
次要结局
- Premedication gabapentin can limit the development of persistent pain and neuropathic pain.(3-mos and 6-mos after surgery)
- Preoperative gabapentin can lead to a decrease incidence of PONV(1 hour,2 hours,1day,2 days after surgery)
研究者
Wei Zhang
attending doctor
Capital Medical University