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The safety and efficacy of Remazolam toluenesulfonic acid for injection combined with sufentanil in hysteroscopic

The safety and efficacy of Remazolam toluenesulfonic acid for injection combined with sufentanil in hysteroscopic

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037813
Enrollment
Unknown
Registered
2020-09-02
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-09

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

Conditions

hysteroscopic surgery

Interventions

control group:Propofol
experimental group:Ramazolam

Sponsors

Department of Anesthesiology, Jiangyin People's Hospital, Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1) Patients undergoing hysteroscopy and treatment; 2) Aged 30-50 years, ASA classification I-II; 3) 20 < BMI < 25kg/m2; 4) Informed consent, voluntarily participate in the trial, and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients allergic to benzodiazepines, opioids, and propofol; 2) Severe cardiac insufficiency, lung insufficiency, liver insufficiency, and renal insufficiency; 3) History of alcohol or drug abuse; 4) Anemia before operation or blood transfusion required during operation; 5) Pregnant women; 6) Patients with mental disorders and myasthenia gravis; 7) Hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs (systolic blood pressure >= 160 mmHg, and/or diastolic blood pressure >= 100 mmHg); 8) Participated in other drug clinical trials as subjects in the past 3 months; 9) The investigator believes that it is inappropriate for patients to participate in this trial or the patients themselves refuse.

Design outcomes

Primary

MeasureTime frame
Induction time (the time from the start of induction to the disappearance of the patient’s consciousness);Recovery time (the time from the end of the operation to the time the patient leaves the operating room);The incidence of adverse reactions (respiratory depression, slow heart rate, hypotension, hypoxemia, injection pain, intraoperative awareness, nausea, vomiting, chills);

Secondary

MeasureTime frame
Operation time;rate of body movement;Blood pressure, heart rate, respiratory rate, blood oxygen saturation, BIS value;Number of remedial cases;Usage rate and dosage of vasoactive drugs;Surgeon satisfaction and patient satisfaction;MOAA/S score;

Countries

China

Contacts

Public ContactJianqing Chen

People's Hospital of Jiangyin City, Jiangsu Province

liuwanchao2017@163.com+86 13606166881

Outcome results

None listed

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