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Effect of Preoperative Anxiety on the ED50 and ED95 of Remimazolam for Loss of Consciousness Induction in Patients Undergoing Hysteroscopy

Effect of Preoperative Anxiety on the ED50 and ED95 of Remimazolam for Loss of Consciousness Induction in Patients Undergoing Hysteroscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115641
Enrollment
Unknown
Registered
2025-12-29
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Effective dose

Interventions

High-anxiety group:Using a modified Dixon up-and-down method, remimazolam besylate for injection was administered intravenously to induce loss of consciousness.
Low-anxiety group:Using a modified Dixon up-and-down method, remimazolam besylate for injection was administered intravenously to induce loss of consciousness.
Non-anxious group:Using a modified Dixon up-and-down method, remimazolam besylate for injection was administered intravenously to induce loss of consciousness.

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Females aged 20–40 years; 2. American Society of Anesthesiologists (ASA) physical status I–II; 3. Body mass index (BMI) 18–25 kg/m²; 4. Scheduled for hysteroscopy requiring intravenous anesthesia; 5. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy to or contraindication for benzodiazepines; 2. Long-term use of sedatives or antidepressants; 3. Severe arrhythmia; 4. Severe organ dysfunction; 5. History of drug or alcohol abuse; 6. Communication barriers or refusal to participate.

Design outcomes

Primary

MeasureTime frame
ED50 and ED95 of remimazolam for loss of consciousness (MOAA/S = 1) induced by remimazolam;

Secondary

MeasureTime frame
Three-minute observation period of vital signs after loss of consciousness induction;On?scene vital signs;hypotension;Sedation induction time;Bradycardia;Respiratory depression;Injection pain;Vital signs at the end of surgery;operative time;

Countries

China

Contacts

Public ContactBin Wang

The First Affiliated Hospital of Chongqing Medical University

774935778@qq.com+86 136 3781 5096

Outcome results

None listed

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