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Comparison of Remimazolam Besylate and Propofol in Hysteroscopic Procedures

Comparison of Remimazolam Besylate and Propofol in Hysteroscopic Procedures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104809
Enrollment
Unknown
Registered
2025-06-24
Start date
2025-06-24
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

None

Interventions

The remimazolam besylate group (Group R) and the propofol group (Group P):Group R (Remimazolam): - Induction: 0.4 mg/kg IV bolus - Maintenance: Continuous infusion at 1 mg/kg/h
The propofol group (Group P):Group P (Propofol): - Induction: 2.0-2.5 mg/kg IV bolus - Maintenance: Continuous infusion at 4-6 mg/kg/h

Sponsors

The Sixth Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 60 years; 2) Patients undergoing hysteroscopic surgery under general anesthesia; 3) ASA physical status = III; 4) Body mass index (BMI) between 18 kg/m^2 and 30 kg/^2; 5) Fully informed about the study and voluntarily participating, with signed informed consent obtained from either the patient or their legally authorized representative.

Exclusion criteria

Exclusion criteria: 1) Severe systemic diseases (ASA physical status = IV); 2) Cognitive dysfunction or psychiatric/psychological disorders; 3) Use of other investigational drugs within 1 month prior to enrollment or current participation in other clinical trials; 4) Uncooperative patients, those lost to follow-up after discharge, or refusal to participate in follow-up; 5) Other conditions deemed by clinicians as unsuitable for study participation.

Design outcomes

Primary

MeasureTime frame
Non-invasive blood pressure ;Pulse oxygen saturation;Heart rate;Bispectral Index Score;Plasma concentration of remimazolam besylate;Plasma concentration of propofol;

Secondary

MeasureTime frame
Body temperature;

Countries

China

Contacts

Public ContactMeng Fanyou

The Sixth Affiliated Hospital of Harbin Medical UniversityLC

mengfanyou1964@163.com+86 130 8999 2433

Outcome results

None listed

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