Feasibility Study on the Use of Osellidine for Perioperative Analgesia in Daytime Hysteroscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 310
- 主要终点
- Incidence of Intraoperative Adverse Events
研究概览
简要总结
While providing equivalent analgesic efficacy, oxelidine significantly reduces the risk of adverse reactions-including respiratory depression, gastrointestinal dysfunction, and cognitive impairment-and facilitates faster recovery of postoperative cognitive orientation. It thus aligns with the core goals of "precise analgesia and rapid recovery" in daytime anesthesia and has been widely adopted in clinical practice. Given the high heterogeneity among day surgery patients (e.g., age, comorbidities, and surgical complexity), real-world studies can better capture a drug's performance across diverse populations. Therefore, this study will use a prospective, observational, real-world design to systematically compare the effects of oxelidine and traditional analgesic regimens in patients undergoing daytime hysteroscopic surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Scheduled to undergo gynecological hysteroscopic surgery under general anesthesia with laryngeal mask airway (LMA).
- •Willing and able to provide written informed consent.
排除标准
- •Incomplete medical records or data.
- •Severe hepatic or renal dysfunction.
- •Concurrent use of other potent analgesics (e.g., opioids, NSAIDs) or medications that may interfere with study outcomes.
- •Participation in another clinical trial within the past 4 weeks
研究组 & 干预措施
Oxelidine Group
Patients who received oxelidine and NSAIDS during anesthesia induction and maintain without other opioid drugs
干预措施: Oxelidine (Drug)
Control Group
Patients who receive traditional opioid drugs during anesthesia induction and maintain, such as afentanil, sufentanil, and remifentanil
干预措施: Sufentanil or Remifentanil (Drug)
结局指标
主要结局
Incidence of Intraoperative Adverse Events
时间窗: Intraoperative period
he incidence of predefined intraoperative adverse events, including but not limited to: Hypotension: blood pressure decreased by more than 20% of the baseline value Hypertension: blood pressure increased by more than 20% of the baseline value Bradycardia: heart rate decreased by more than 20% of the baseline value Tachycardia: blood pressure increased by more than 20% of the baseline value
次要结局
- Pain Score (Visual Analog Scale, VAS)(immediately upon emergence from anesthesia, at the time of discharge from the Post-Anesthesia Care Unit (PACU), and at 24 hours postoperatively)
- Postoperative recovery quality（Quality of Recovery-15 score, QoR-15）(24 hours after the operation)
- Sleep Quality (Richards-Campbell Sleep Questionnaire, RCSQ)(Assessed at 24 hours postoperatively, referring to the sleep quality of the first postoperative night)
- Incidence of Postoperative Adverse Events(24 hours postoperatively)