Network Pharmacology Was Applied to Explore the Mechanism of Remimazolam Applied in General Anesthesia for Gynecological Surgeries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam, propofol.
- Who it may be relevant to
- Registry conditions: Gynecological Disease. Basic parameters: 18 years — 64 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Drug Remimazolam
Remimazolam, sufentanil and rocuronium were used during induction, and remimazolam and refentanil were used during maintenance - Drug propofol
Propofol, sufentanil and rocuronium were used during induction, and propofol and remifentanil were used during maintenance
Primary outcome measures
- Levels of serum N/OFQ, IL-6, STAT3 [Time frame: perioperatively/periprocedurally]
Secondary outcome measures (2)
- Heart rate [Time frame: during the surgery]
- mean arterial pressure [Time frame: during the surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06990763 · Hanyi20250408