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NCT Number: NCT06990763

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Remimazolam

Drug

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

Propofol

Drug

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

Primary outcomes

  1. Levels of serum N/OFQ, IL-6, STAT3

    Time frame: perioperatively/periprocedurally

Secondary outcomes

  1. Heart rate

    Time frame: during the surgery

  2. mean arterial pressure

    Time frame: during the surgery

Study contacts

Contact information is provided by the study sponsor or research team.

ran Zhang

CONTACT

[email protected]

17835158352

Sponsors and collaborators

Lead sponsor

Second Hospital of Shanxi Medical University

Other

Registry information

Official study title

Clinical and Molecular Mechanism Study of Remimazolam Regulating the N/OFQ-inflammation-immune Axis to Optimize the Effect of General Anesthesia in Gynecological Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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