Skip to content

ED95 Dose of Alfentanil Combined with Remimazolam for Effective Analgesia in Painless Hysteroscopy: A Dose-Finding Study"

"ED95 Dose of Alfentanil Combined with Remimazolam for Effective Analgesia in Painless Hysteroscopy: A Dose-Finding Study"

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103435
Enrollment
Unknown
Registered
2025-05-29
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

patients undergoing hysteroscopy

Interventions

Remimazolam high-dose group (0.3 mg/kg):The initial dose of alfentanil is 10 ug/kg, and the sequential dose is 1 ug/kg.
Remimazolam low-dose group (0.2 mg/kg):The initial dose of alfentanil is 10 ug/kg, and the sequential dose is 1 ug/kg.

Sponsors

The First Affiliated Hospital of Shan Tou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old, female, BMI 18-30 kg/m^2; 2. ASA (American Society of Anesthesiologists) physical status I-II; 3. Scheduled for hysteroscopy; 4. Informed consent obtained; 6.BMI 18-24 kg/m²;

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation; 2. Known history of allergy to opioids (e.g., alfentanil) or benzodiazepines (e.g., remimazolam); 3. Long-term use of sedatives, analgesics, or antidepressants (>3 months); 4. Severe cardiovascular diseases (e.g., uncontrolled hypertension, arrhythmias, cardiac function class III-IV); 5. Psychiatric disorders or communication impairments preventing cooperation with assessments; 6. Severe hepatic or renal dysfunction (ALT/AST > 2× upper limit of normal [ULN], serum creatinine [Cr] > 1.5× ULN); 7. Patients with myasthenia gravis;

Design outcomes

Primary

MeasureTime frame
Alfentanil Dosing for Effective Pain Control During Hysteroscopy;

Secondary

MeasureTime frame
Ramsay Sedation Score;Adverse Event Outcomes;Vital signs: MAP, HR, SpO2;

Countries

China

Contacts

Public ContactWei Sun

The First Affiliated Hospital of Shan Tou University Medical College

md.sunwei@gmail.com+86 13580579456

Outcome results

None listed

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