Gynecological Disease
Conditions
Keywords
remimazolam, propofol, gynecological disease
Brief summary
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.
Detailed description
①Clinical effect evaluation of remimazolam 1. 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. 2. 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.
Interventions
DRUGRemimazolam
Remimazolam, sufentanil and rocuronium were used during induction, and remimazolam and refentanil were used during maintenance
DRUGpropofol
Propofol, sufentanil and rocuronium were used during induction, and propofol and remifentanil were used during maintenance
Sponsors
Second Hospital of Shanxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. The patient or their family members sign the informed consent form 2. Age: 18-64 years old, BMI: 18-30kg/m2 3. ASA Grade Ⅰ or Ⅱ 4. Patients undergoing gynecological surgeries (laparoscopic total hysterectomy, adnexectomy and myomectomy)
Exclusion criteria
1. People who are allergic to remimazolam or benzodiazepinesThyroid disease 2. Long-term use of benzodiazepines 3. Pregnancy or lactation 4. Have a history of drug abuse or alcoholism 5. Patients with contraindications for surgery 6. 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%) 7. Patients with arrhythmia, heart failure, renal failure, and those who have recently taken cardiovascular active drugs 8. Endocrine disorders such as hyperthyroidism and pheochromocytoma that may affect the hemodynamic level of the body 9. Patients with ketoacidosis and lactic acidosis 10. Abnormal liver function, ALT\> three times the upper limit of the normal value; 11. Renal failure (serum creatinine \>3mg/dl or creatinine clearance rate \<30ml/min) 12. Patients who have been using sedatives or antidepressants for a long time, or have a history of alcohol abuse or drug dependence 13. Asthma or reactive airway diseases 14. Combined with underlying cognitive function abnormalities 15.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of serum N/OFQ, IL-6, STAT3 | perioperatively/periprocedurally |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate | during the surgery |
| mean arterial pressure | during the surgery |
Contacts
Primary Contactran Zhang
Outcome results
None listed