Network Pharmacology Was Applied to Explore the Mechanism of Remimazolam Applied in General Anesthesia for Gynecological Surgeries

NCT ID: NCT06990763

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-01-01

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.

Conditions

Gynecological Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Remimazolam group

Remimazolam was used for anesthesia induction and maintenance

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

Remimazolam, sufentanil and rocuronium were used during induction, and remimazolam and refentanil were used during maintenance

Propofol group

Anesthesia induction and maintenance were carried out using propofol

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

Propofol, sufentanil and rocuronium were used during induction, and propofol and remifentanil were used during maintenance

Interventions

Remimazolam

Remimazolam, sufentanil and rocuronium were used during induction, and remimazolam and refentanil were used during maintenance

Intervention Type: DRUG

propofol

Propofol, sufentanil and rocuronium were used during induction, and propofol and remifentanil were used during maintenance

Intervention Type: DRUG

Eligibility Criteria

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)

17. Those who experienced adverse events such as shock, severe hypotension and severe arrhythmia during the operation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zheng Guo

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yi Han

Role: STUDY_DIRECTOR

Second Hospital of Shanxi Medical University

Central Contacts

ran Zhang

Role: CONTACT

17835158352@163.com

17835158352

Other Identifiers

Hanyi20250408

Identifier Type: -

Identifier Source: org_study_id