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A randomized, controlled clinical study of the safety and efficacy of remazolam in patients undergoing hysteroscopy for infertility

A randomized, controlled clinical study of the safety and efficacy of remazolam in patients undergoing hysteroscopy for infertility

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066612
Enrollment
Unknown
Registered
2022-12-12
Start date
2022-12-12
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Anesthesia in infertile patients undergoing hysteroscopy

Interventions

Group propofol:propofol 1~2mg/kg
Group remimazolam:remimazolam 0.1~0.2mg/kg

Sponsors

The First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) 18 years old = age =45 years old; (2) ASA I-II; (3) BMI =35 kg/m2; (4) Infertile patients scheduled for painless hysteroscopy; (5) Able to understand and voluntarily sign informed consent, and willing to comply with the requirements of the trial protocol.

Exclusion criteria

Exclusion criteria: (1) Allergic or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone and other drugs and their drug components; (2) A history of severe heart, liver, lung and kidney dysfunction, bronchial asthma, and recent symptoms of upper respiratory tract infection; (3) Patients with a history of alcohol abuse, opioid allergy, or opioid abuse; (4) Patients with severe uncontrolled hypertension; (5) Other conditions considered by the investigator to be unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
blood pressure;heart rate;Anxiety and depression score;VAS pain grade;Anesthesia satisfaction score;

Secondary

MeasureTime frame
Onset time of sedation;wake up time;Shaking their heads and crying after surgery;Tolerance of balloon compression;Other related complications;

Countries

China

Contacts

Public ContactChaoliang Tang

The First Affiliated Hospital of University of Science and Technology of China

chaolt@ustc.edu.cn13866777142

Outcome results

None listed

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