Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Two segment sensory block regression time
研究概览
简要总结
Intravenous infusion of dexmedetomidine during procedure was known to be associated prolonged duration of spinal anesthesia. In patients receiving dexmedetomidine infusion during procedure, it has been not evaluated whether use of adjuvant intrathecal fentanyl had additional prolonging effect on duration of spinal anesthesia or not. Therefore, the investigators planned this trial to compare clinical outcomes in patients receiving spinal anesthesia with heavy bupivacaine only and heavy bupivacaine plus fentanyl adjuvant.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing total knee replacement arthroplasty under spinal anesthesia
排除标准
- •Contraindication of spinal anesthesia
- •inability to communicate
- •morbid obesity (BMI > 30kg/m2)
- •spine abnormality
- •severe cardiac dysfunction
- •Height <155cm, or > 180cm
- •contraindication to fentanyl
研究组 & 干预措施
intrathecal fentanyl
heavy bupivacaine 14mg and fentanyl 20mcg will be injected intrathecally during spinal anesthesia
干预措施: fentanyl (Drug)
bupivacaine only
heavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia
干预措施: bupivacaine only (Drug)
结局指标
主要结局
Two segment sensory block regression time
时间窗: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
Time from highest sensory block level to two segment regression
次要结局
- postoperative pain score(at op day, at postoperative 1st day, at postoperative 2nd day)
- motor block(From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours)
- intraoperative incidence of hypotension(From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours)
- postoperative nausea and vomiting(at op day, at postoperative 1st day, at postoperative 2nd day)
研究者
Jin-Tae Kim
Associate professor
Seoul National University Hospital