Effect of Propofol in Combination With Oxycodone on Anxiety State in Painless Abortion - A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- anxiety scores
研究概览
简要总结
In this study, 300 patients who underwent painless abortion in Ruijin Hospital and sub-central hospitals were selected through a multi-center randomized controlled study, and 300 patients who underwent painless abortion in Ruijin Hospital and each sub-center hospital were divided into intravenous anesthesia with propofol with fentanyl (group F) and propofol with oxycodone (group O) by stratified group randomization method 1:1. The difference between the postoperative anxiety scores and depression scores of the two groups was observed, and the postoperative anxiety, depression and numerical pain scores were recorded. Finally, the relevant data were statistically analyzed and conclusions were drawn.
详细描述
This study is a multicenter, randomized controlled clinical study. A total of 300 patients who underwent elective painless abortion surgery in Ruijin Hospital and other sub-central hospitals were enrolled, and they were randomly divided into 1:1 patients who received intravenous anesthesia with propofol with fentanyl (group F) and propofol with oxycodone (group O). The scores of anxiety, depression and postoperative numerical rating scale (NRS) before and after surgery were observed, and the levels of serum stress response factors and inflammatory cytokines were monitored. The effects of oxycodone on anxiety, depression and postoperative acute pain in patients with painless abortion were investigated.
- Main observation indicators:
The difference between the post-operative anxiety score and the preoperative anxiety score 2. Secondary Observational Indicators:
- Post-operative anxiety score
- The difference between the post-operative depression score and the preoperative depression score
- Post-operative depression score
- Pain assessment after surgical recovery (NRS)
- Laboratory tests
- Patient and family satisfaction with postoperative analgesic treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years old
- •Gestational age 6-12 weeks
- •American Society of Anesthesiologists （ASA） Grading I-II
- •Fluent communicator and able to complete self-rating scales on her own
- •Voluntarily participate and sign the informed consent form
排除标准
- •Patients who are allergic to anesthetic drugs such as propofol, oxycodone, fentanyl, etc., or who have had other anesthetic adverse events
- •Patients with anxiety or depression
- •Presence of organic mental disorders, mental retardation
- •Severe acute and chronic infection, severe heart, liver and kidney insufficiency
- •Patients with complications or bleeding > 50ml during surgery
研究组 & 干预措施
group Fentanyl
intravenous anesthesia with propofol with fentanyl
干预措施: Fentanyl (as Citrate) (Drug)
group Oxycodone
intravenous anesthesia with propofol with oxycodone
干预措施: Fentanyl (as Citrate) (Drug)
结局指标
主要结局
anxiety scores
时间窗: 20-30 minutes postoperative
postoperative anxiety scores
次要结局
- depression scores(20-30 minutes postoperative)