Comparison of Postoperative Side Effects and Analgesic Quality According to the Combination of Fentanyl and Ketorolac Versus Fentanyl After Laparoscopic Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in the occurrence of postoperative nausea
研究概览
简要总结
In laparoscopic gynecological surgery, when intravenous patient-controlled analgesia (IV-PCA) device is used after surgery, the degree of postoperative side effects and pain control is compared when a combination of fentanyl and ketorolac is administered compared to when fentanyl alone is used.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiology physical status 1 or 2
- •Patients scheduled for gynecological laparoscopic surgery under general anesthesia
- •Patients who applied for the use of IV-PCA after surgery
排除标准
- •Patients with side effects of opioids
- •Patients with hypersensitivity to aspirin or non-steroid anti-inflammatory drugs
- •Patients with alcohol or drug dependence
- •Patients with peptic ulcers, patients with gastrointestinal bleeding
- •Patients with suspected cerebrovascular hemorrhage, organic disorders, or damage to the head related to increased intracranial pressure
- •Symptoms of bronchial asthma or bronchospasm
- •Patients with severe respiratory depression
- •Moderate to severe renal impairment
- •Patients with reduced blood volume or dehydration
- •polyps in the nose
- •angioedema
- •Patients with or a history of the convulsive disease
- •Patients for whom the use of neuromuscular blocking agents is contraindicated
研究组 & 干预措施
Dual group
The two drugs are administered separately.
干预措施: Fentanyl selector (Drug)
Dual group
The two drugs are administered separately.
干预措施: Ketorolac continuous (Drug)
Single group
One drug is administered alone.
干预措施: Fentanyl selector (Drug)
Single group
One drug is administered alone.
干预措施: Fentanyl continuous (Drug)
结局指标
主要结局
Change in the occurrence of postoperative nausea
时间窗: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Confirm the occurrence of postoperative nausea.
Change in the occurrence of postoperative vomiting
时间窗: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Confirm the occurrence of postoperative vomiting.
次要结局
- Change in the use of rescue antiemetics(postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour)
- Change of postoperative pain score(postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour)
- Change in the use of rescue analgesics(postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour)
研究者
Hyo-Seok Na
Principal Investigator
Seoul National University Bundang Hospital