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Safety and efficacy of remazolam combined with low-dose propofol sedation for hysteroscopic surgery-a prospective, randomized, double-blind, parallel-controlled study

Safety and efficacy of remazolam combined with low-dose propofol sedation for hysteroscopic surgery-a prospective, randomized, double-blind, parallel-controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100055034
Enrollment
Unknown
Registered
2021-12-31
Start date
2021-12-31
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

endometrial and other intrauterine diseases

Interventions

Control group 1:propofol+alfentanil
Control group 2:remazolam+alfentanil
Experimental group:remazolam+low-dose propofol+alfentanil

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-55 years, female; 2. Accept painless hysteroscopy diagnosis and treatment; 3. ASA classification is I or II; 4. BMI 18-28kg/m^2; 5. Voluntarily participate in this study and sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe liver and kidney insufficiency; 2. Patients with central nervous system diseases; mental system diseases (schizophrenia, mania, insanity, etc.) and long-term use of sedatives or pain relievers; 3. Patients with a history of craniocerebral injury and/or cerebrovascular accident; those with possible intracranial hypertension and cerebral aneurysm; 4. Heart failure (NYHA class III-IV); unstable angina pectoris; myocardial infarction within 6 months before screening; resting ECG heart rate =450ms, female >=470ms; 5. Those who are allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone and other drugs and their components; 6. Patients who are judged to have difficulty in airway management: modified Markov score grade III and above; 7. Other conditions judged by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Pulse oximetry;

Secondary

MeasureTime frame
Bispectral index;Surgical pleth index;Injection pain;Body movement response;Time to wake up;

Countries

China

Contacts

Public ContactLiao Qin

The Third Xiangya Hospital of Central South University

xy3yyliaoqin@sina.com+86 13787412348

Outcome results

None listed

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