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The 90% Effective Dose of Tigecycline Fumarate Injection Combined with Remimazolam for Analgesia in Outpatient Hysteroscopic Surgery

The 90% Effective Dose of Tigecycline Fumarate Injection Combined with Remimazolam for Analgesia in Outpatient Hysteroscopic Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112774
Enrollment
Unknown
Registered
2025-11-19
Start date
2025-11-24
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hysteroscopic surgery

Interventions

Phase I: Experimental Group (T Group):Teglicarpidine combined with remimazolam. The dosage of teglicarpidine for the next patient is dynamically adjusted based on the surgical analgesic effect of the
Phase I: Control Group (S Group):Sufentanil combined with remimazolam. The dosage of sufentanil for the next patient is dynamically adjusted based on the surgical analgesic effect of the previous pati
Phase II: Experimental Group (T Group):Combined with remimazolam, the ED90 of Teglicarpidine obtained by the BCD sequential method in the first phase.
Phase II: Control Group (S Group):Combined with remimazolam, the ED90 of sufentanil obtained by the BCD sequential method in the first phase.

Sponsors

Xiangyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective hysteroscopic surgery; 2. Aged 18-60 years; 3. American Society of Anesthesiologists (ASA) physical status classification ?-II; 4. Body Mass Index (BMI) 18-25 kg/m²; 5. No preoperatively diagnosed respiratory diseases and normal airway assessment.

Exclusion criteria

Exclusion criteria: 1. Refusal to sign the informed consent form; 2. Allergy to the experimental drugs; 3. Abnormal vital signs of clinical significance or abnormal results of clinical laboratory tests; 4. Long-term use of opioids, analgesics, sedatives, or a history of alcoholism; 5. Presence of mental illness or inability to communicate.

Design outcomes

Primary

MeasureTime frame
90% Effective Dose (ED90) of Teglidipine Fumarate Combined with Remimazolam for Hysteroscopic Surgery;

Secondary

MeasureTime frame
Incidence of perioperative respiratory depression;Postoperative NRS score;Satisfaction scores of patients, anesthesiologists, and endoscopists;Hemodynamic parameters (blood pressure and heart rate) at each time point;Intraoperative adverse event rate;Incidence of postoperative nausea and vomiting (PONV);

Countries

China

Contacts

Public ContactQinyi Chen

Xiangyang Central Hospital

348847301@qq.com+86 188 7101 7092

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026