Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain on the VAS scale
研究概览
简要总结
The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.
详细描述
Sufentanil is a classical drug for postoperative analgesia. Dexmedetomidine is a commonly used α2-adrenergic receptor, and it helps provide sedation, analgesia and inhibition of sympathetic activation. The investigators propose to recruit 120 patients who is undergoing the arteriovenous malformation embolism operation in department of Neurosurgery. Patients will be randomly divided into 4 groups(control group, sufentanil and low dexmedetomidine dose group, sufentanil and middle dexmedetomidine dose group, sufentanil and high dexmedetomidine dose group), then the investigators select post-operative records to determine whether dexmedetomidine can take a positive role in neurosurgical analgesia.
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
- Single (Participant)
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
- •patients undergoing venous malformation embolization operation through general anesthesia.
- •aged 18-65 years old.
- •operating time varies 1-4h,and extubation after the operation.
排除标准
- •long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history.
- •known for dexmedetomidine or other drugs allergy in this study.
- •cannot communicate.
- •preoperative systolic blood pressure <90 mmHg, or the heart rate <50/min.
研究组 & 干预措施
sufentanil
sufentanil 150μg，intravenous administration during the following 72 hours after operation.
干预措施: Sufentanil (Drug)
sufentanil&dexmedetomidine 1
sufentanil 150μg，dexmedetomidine 0.05μg/kg/h，intravenous administration during the following 72 hours after operation.
干预措施: Sufentanil (Drug)
sufentanil&dexmedetomidine 1
sufentanil 150μg，dexmedetomidine 0.05μg/kg/h，intravenous administration during the following 72 hours after operation.
干预措施: dexmedetomidine 1 (Drug)
sufentani&dexmedetomidine 2
sufentanil 150μg，dexmedetomidine 0.1μg/kg/h，intravenous administration during the following 72 hours after operation.
干预措施: Sufentanil (Drug)
sufentani&dexmedetomidine 2
sufentanil 150μg，dexmedetomidine 0.1μg/kg/h，intravenous administration during the following 72 hours after operation.
干预措施: dexmedetomidine 2 (Drug)
sufentanil&dexmedetomidine 3
sufentanil 150μg，dexmedetomidine 0.15μg/kg/h ，intravenous administration during the following 72 hours after operation.
干预措施: Sufentanil (Drug)
sufentanil&dexmedetomidine 3
sufentanil 150μg，dexmedetomidine 0.15μg/kg/h ，intravenous administration during the following 72 hours after operation.
干预措施: dexmedetomidine 3 (Drug)
结局指标
主要结局
Pain on the VAS scale
时间窗: within the following 72 hours after surgery
measure the VAS score at pre-operative day and post-operative 4h、8h、12h、24h、48h、72h。
次要结局
- blood pressure(BP)(mmHg)(within the following 72 hours after surgery)
- heart rate(HR) (/min)(within the following 72 hours after surgery)
- spO2(%)(within the following 72 hours after surgery)
- breath(/min)(within the following 72 hours after surgery)
- sedation level on ramsay sedation score(within the following 72 hours after surgery)
- vomit times(within the following 72 hours after surgery)
- nausea(within the following 72 hours after surgery)
研究者
Xinxin Shao
resident
First Affiliated Hospital, Sun Yat-Sen University