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Safety and Efficacy Analysis of Remimazolam Combined with the Biased µ Receptor Agonist Tagelidine in Short-Duration Hysteroscopic Surgery

Safety and Efficacy Analysis of Remimazolam Combined with the Biased µ Receptor Agonist Tagelidine in Short-Duration Hysteroscopic Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121281
Enrollment
Unknown
Registered
2026-03-27
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Anesthesia for short-duration hysteroscopic surgery

Interventions

Trial Group:Induction: Tegeline 10µg/kg infusion over 10 minutes + Remazolam 0.3mg/kg intravenous injection
Maintenance: Remazolam 1mg/kg/h continuous intravenous infusion. Intraoperative rescue: Add Tegeline 0.25mg for movement, manage respiratory depression according to standard protocol.
Control Group:Induction: Sufentanil 0.1µg/kg intravenous injection + Propofol 2mg/kg intravenous injection
Maintenance: Propofol 6mg/kg/h continuous intravenous infusion. Intraoperative rescue: Add Sufentanil 0.05µg/kg for movement. Both groups received pre-treatment with Oubai 4mg + Ketorolac 30mg intrave

Sponsors

Maternal and Child Health Hospital of Jiangxi Province
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Aged 18–65 years, ASA physical status I–III; 2. Scheduled for hysteroscopic surgery, including endometrial polypectomy, submucous myomectomy, cervical polyp resection, intrauterine device removal, etc.; 3. Expected operative duration = 30 minutes; 4. Patients and their families provided informed consent and signed the informed consent form; 5. No history of drug allergy (no allergy to study or control drugs).

Exclusion criteria

Exclusion criteria: 1. Severe hepatic or renal dysfunction (Child-Pugh class C liver dysfunction, creatinine clearance < 30 mL/min); 2. Coagulation disorders; 3. Severe cardiovascular diseases (e.g., heart failure, severe arrhythmia, uncontrolled hypertension, etc.); 4. Psychiatric disorders or cognitive impairment that prevent cooperation with the study; 5. Pregnant or lactating women; 6. Recent use (within 1 month) of strong inhibitors of CYP3A4/CYP2D6 (e.g., paroxetine).

Design outcomes

Primary

MeasureTime frame
Postoperative awakening time;

Secondary

MeasureTime frame
Incidence of intraoperative movement;Incidence of adverse events including intraoperative respiratory depression, postoperative nausea, and postoperative vomiting;Hemodynamic stability during surgery (changes in systolic blood pressure, diastolic blood pressure, and heart rate);Patient satisfaction with anesthesia;

Countries

China

Contacts

Public ContactLi Huanhuan

Jiangxi Maternal and Child Health Hospital

446019174@qq.com+86 159 7904 8151

Outcome results

None listed

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