NCT05189704招募中不适用
The Effect of Patient-controlled Analgesia (Ketorolac vs. Fentanyl) on the Development of Postoperative Nausea and Vomiting in Patients Undergoing Microvascular Decompression: a Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Postoperative nausea and vomiting
研究概览
简要总结
This study is a randomized, controlled, double-blinded, and parallel design study. A total 94 patients will be randomized to receive ketorolac or fentanyl based patient-controlled analgesia after microvascular decompression surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo elective microvascular decompression surgery
- •American Society of Anesthesiologists grade 1 or 2
- •19 - 65 years old
排除标准
- •Refuse to participate to the study
- •Refuse to use Patient-controlled analgesia
- •Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
- •history of craniotomy or chemotheraphy
- •Patients who used preoperative antiemetics within 24h before surgery
- •Severe renal or hepatic dysfunction
研究组 & 干预措施
NSAID group
Experimental
NSAID based patient-controlled analgesia will connected to intravenous line for pain control.
干预措施: NSAID (Drug)
Opioid group
Active Comparator
Opioid based patient-controlled analgesia will connected to intravenous line for pain control.
干预措施: Opioid (Drug)
结局指标
主要结局
Postoperative nausea and vomiting
时间窗: postoperative 48 hours
Incidence
次要结局
- Postoperative pain(Postoperative 30 minutes, 1 hours, 24 hours, 48 hours)
- Rescue antiemetics requirement(Postoperative 30 minutes, 1 hours, 24 hours, 48 hours)
- Rescue analgesic requirement(Postoperative 30 minutes, 1 hours, 24 hours, 48 hours)
- Satisfaction score for postoperative nausea and vomiting(postoperative 48 hours)
- Postoperative nausea and vomiting(Postoperative 30 minutes, 1 hours, 24 hours, 48 hours)
- Postoperative PCA consumption(Postoperative 30 minutes, 1 hours, 24 hours, 48 hours)
- Satisfaction score for postoperative pain(postoperative 48 hours)
研究者
Chang-Hoon Koo
Assistant professor
Seoul National University Bundang Hospital
研究点 (1)
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