Efficacy and safety of Remazolam toluene sulfonate in hysteroscopic surgery under BIS monitoring

fficacy and safety of Remazolam toluene sulfonate in hysteroscopic surgery under BIS monitoring

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200066744

Enrollment

Unknown

Registered

2022-12-15

Start date

2022-12-26

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 for hysteroscopic surgery

Interventions

Propofol group:N/A

Remazolam group:N/A

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Criteria for inclusion 1.ASA I-II grade; Age 18-60; BMI18-28; Female patients; 2. Patients with general anesthesia who were to undergo hysteroscopic surgery.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patients with psychiatric diseases and a history of long-term use of psychotropic drugs; 2. Complicated with heart, liver, lung and kidney diseases and uncontrolled hypertension (systolic blood pressure >160mmHg, diastolic blood pressure >90mmHg); 3. Severe arrhythmia, hypovolemia, shock or coma; 4. People with cognitive dysfunction; Allergic to or contraindicated to benzodiazepines; Pregnant or nursing female patients; 5. Used other sedatives in the past week; Participated in drug clinical trials as a subject within the last 3 months.

Design outcomes

Primary

Measure	Time frame
HR;MAP;SPO2;BIS;	—

Secondary

Measure	Time frame
injection pain;Body moving;drowsiness;nausea and vomiting;	—

Countries

China

Contacts

Public ContactShenglan Mei

Department of Anesthesiology, Renmin Hospital of Wuhan University

meishengl@163.com18827381696

Outcome results

None listed

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