NCT06990763尚未招募不适用
Clinical and Molecular Mechanism Study of Remimazolam Regulating the N/OFQ-inflammation-immune Axis to Optimize the Effect of General Anesthesia in Gynecological Surgery
Second Hospital of Shanxi Medical University0 个研究点目标入组 40 人开始时间: 2025年6月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Levels of serum N/OFQ, IL-6, STAT3
研究概览
简要总结
To explore the related mechanisms by which remimazolam regulates hemodynamic stability, inflammatory factors and the immune system in patients undergoing general anesthesia for gynecological surgeries.
详细描述
①Clinical effect evaluation of remimazolam
- Compare the hemodynamic stability (heart rate, mean arterial pressure, blood oxygen saturation), anesthesia efficiency (induction time, recovery time), and safety (incidence of adverse reactions such as hypotension, hypoxemia, and injection pain) of remimazolam alone, propofol alone, and their combination in general anesthesia for gynecological surgeries.
- Clarify the optimal dose range of remimazolam and its synergistic effect with propofol, and optimize the anesthetic medication regimen.
- The regulatory effect of remimazolam on the inflammation-immune axis and oxidative stress Detect the dynamic changes of serum inflammatory factors (IL-6, IL-10, TNF-α), immune indicators (CD3+, CD4+, CD4+/CD8+) and oxidative stress markers (SOD, MDA) of patients before and after the operation, and analyze the regulatory effect of remimazolam on the above indicators.
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient or their family members sign the informed consent form
- •Age: 18-64 years old, BMI: 18-30kg/m2
- •ASA Grade Ⅰ or Ⅱ
- •Patients undergoing gynecological surgeries (laparoscopic total hysterectomy, adnexectomy and myomectomy)
排除标准
- •People who are allergic to remimazolam or benzodiazepinesThyroid disease
- •Long-term use of benzodiazepines
- •Pregnancy or lactation
- •Have a history of drug abuse or alcoholism
- •Patients with contraindications for surgery
- •Patients with hypertension (clinically diagnosed with hypertension) and patients with coronary heart disease (with typical angina pectoris symptoms and excluding aortic valve lesions, with a clear history of old myocardial infarction, with a clear history of acute myocardial infarction, and CAG finding coronary artery stenosis greater than or equal to 70%)
- •Patients with arrhythmia, heart failure, renal failure, and those who have recently taken cardiovascular active drugs
- •Endocrine disorders such as hyperthyroidism and pheochromocytoma that may affect the hemodynamic level of the body
- •Patients with ketoacidosis and lactic acidosis
- •Abnormal liver function, ALT> three times the upper limit of the normal value;
- •Renal failure (serum creatinine >3mg/dl or creatinine clearance rate <30ml/min)
- •Patients who have been using sedatives or antidepressants for a long time, or have a history of alcohol abuse or drug dependence
- •Asthma or reactive airway diseases
- •Combined with underlying cognitive function abnormalities
- •Exclusion criteria for research subjects
- •Those who were mistakenly included without meeting the inclusion criteria
- •Those who experienced adverse events such as shock, severe hypotension and severe arrhythmia during the operation
研究组 & 干预措施
Remimazolam group
Experimental
Remimazolam was used for anesthesia induction and maintenance
干预措施: Remimazolam (Drug)
Propofol group
Active Comparator
Anesthesia induction and maintenance were carried out using propofol
干预措施: propofol (Drug)
结局指标
主要结局
Levels of serum N/OFQ, IL-6, STAT3
时间窗: perioperatively/periprocedurally
次要结局
- Heart rate(during the surgery)
- mean arterial pressure(during the surgery)
研究者
Zheng Guo
professor
Second Hospital of Shanxi Medical University
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