Gynecological DiseaseNCT06990763
Network Pharmacology Was Applied to Explore the Mechanism of Remimazolam Applied in General Anesthesia for Gynecological Surgeries
A study testing Remimazolam and propofol in people with Gynecological Disease, run by Second Hospital of Shanxi Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Gynecological Disease
- What is being tested?
- Remimazolam and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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%)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Gynecological Disease
- Being tested
- Remimazolam, propofol
- Keywords
- remimazolam, propofol, gynecological disease
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam, sufentanil and rocuronium were used during induction, and remimazolam and refentanil were used during maintenance
propofolDrug
Propofol, sufentanil and rocuronium were used during induction, and propofol and remifentanil were used during maintenance
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Remimazolam was used for anesthesia induction and maintenance Receives: Drug: Remimazolam |
| Propofol group | Active comparator | Anesthesia induction and maintenance were carried out using propofol Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of serum N/OFQ, IL-6, STAT3
Measured: perioperatively/periprocedurally
Secondary outcomes (2)
Heart rate
Measured: during the surgery
mean arterial pressure
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
- Investigators
- yi Han, Study director, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990763
- Sponsor's protocol ID
- Hanyi20250408
- Status last verified
- May 2025
- First submitted
- 20 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06990763
- Acronym / sponsor ID
- Hanyi20250408
- Conditions
- Gynecological Disease
- Keywords
- remimazolam, propofol, gynecological disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: RemimazolamRemimazolam was used for anesthesia induction and maintenance |
| Propofol group | Active comparator | Drug: propofolAnesthesia induction and maintenance were carried out using propofol |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamRemimazolam, sufentanil and rocuronium were used during induction, and remimazolam and refentanil were used during maintenance | Drug | Remimazolam group |
| propofolPropofol, sufentanil and rocuronium were used during induction, and propofol and remifentanil were used during maintenance | Drug | Propofol group |
Primary outcome
Levels of serum N/OFQ, IL-6, STAT3
Time frame: perioperatively/periprocedurally
2 secondary outcomes
Heart rate
Time frame: during the surgery
mean arterial pressure
Time frame: during the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
yi Han study director
Second Hospital of Shanxi Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and propofol in people with Gynecological Disease, run by Second Hospital of Shanxi Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ran Zhang (17835158352, 17835158352@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of serum N/OFQ, IL-6, STAT3 (time frame: perioperatively/periprocedurally). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.