Safety, Efficacy of Remimazolam Tosilate used in Hysteroscopy: a Randomized, Single-Blind, Controlled Trial

Safety, Efficacy of Remimazolam Tosilate Used in Hysteroscopy: a Randomized Controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000033726

Enrollment

Unknown

Registered

2020-06-11

Start date

2020-06-20

Completion date

Unknown

Last updated

2020-07-20

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

Conditions

hysteroscopy

Interventions

Propofol positive control group (Group C):Sufentanil was given 5ug intravenously. After 10 minutes, the patient was given a propofol load (1-2) mg/kg intravenously. When the patient lost consciousne

Remimazolam 1 group (R1 group):Sufentanil 5ug intravenously, after 10 minutes, the patient was given intravenous injection of 6mg/kg/h of Remimazolam, when the patient lost consciousness, and the BIS

Remimazolam 2 group (R2 group):Sufentanil 5ug intravenous infusion, after 10 minutes, the patient was given intravenous injection of 6mg/kg/h of Remimazolam, When the patient lost consciousness and t

Remimazolam 3 group (R3 group) :Sufentanil 5ug intravenous infusion, after 10 minutes the patient was given intravenous injection of 6mg/kg/h of Remimazolam, When the patient lost consciousness and t

Eligibility

Sex/Gender

Female

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients undergoing hysteroscopy and treatment, aged 18-60 years, BMI 18.5-28kg/m2, ASA grade I-III.

Exclusion criteria

Exclusion criteria: 1. Allergic to propofol and Remimazolam; 2. Severe cardiac insufficiency, pulmonary insufficiency, liver insufficiency, renal insufficiency; 3. History of alcohol or drug abuse; 4. Preoperative anemia or intraoperative blood transfusion; 5. Pregnant women; 6. Mental disorders patients; 7. Patients participated in other clinical trials within 1 month before the study.

Design outcomes

Primary

Measure	Time frame
Number of remedial cases;Failure rate;PSI values at various time points ;	—

Secondary

Measure	Time frame
Induction time;Operation time;Wake-up time;blood pressure;Heart rate;breath rate;SpO2;Uterine contraction pain;Adverse reactions (respiratory depression, slow heart rate, muscle tremor, headache, hypotension, injection pain, intraoperative awareness, itching, cough, nausea, sweating, chills, vomiting, dizziness);Vascular active drug usage rate;Assisted respiration rate;Assisted respiration rate;Incidence of circulatory adverse events;Respiratory depression cases;	—

Measure

Time frame

Induction time;Operation time;Wake-up time;blood pressure;Heart rate;breath rate;SpO2;Uterine contraction pain;Adverse reactions (respiratory depression, slow heart rate, muscle tremor, headache, hypotension, injection pain, intraoperative awareness, itching, cough, nausea, sweating, chills, vomiting, dizziness);Vascular active drug usage rate;Assisted respiration rate;Assisted respiration rate;Incidence of circulatory adverse events;Respiratory depression cases;

—

Countries

China

Contacts

Public ContactWei Lai

Department of Anesthesiology, Hunan Provincial People's Hospital

448027999@qq.com+86 13975856480

Outcome results

None listed

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