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The sedative effect of reazolam combined with alfentanil and median effective dose

The sedative effect of reazolam combined with alfentanil and median effective dose

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071424
Enrollment
Unknown
Registered
2023-05-15
Start date
2023-05-15
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Painless hysteroscopy

Interventions

A group :First dose induction of 0.2mg / kg Remazolam was given during hysteroscopic surgery
B group :First dose induction of 0.25mg / kg Remazolam was given during hysteroscopic surgery
C group :First dose induction of 0.3mg / kg Remazolam was given during hysteroscopic surgery
D group :The first dose induction of propofol at 2mg / kg during hysteroscopic surgery
Remazolam+alfentanil:Remazolam+alfentanil

Sponsors

Nanhua Hospital affiliated to Nanhua University, Hengyang City, Hunan Province
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1)Patient aged 25 to 65 years, female patient, body mass index (BMI) 18 to 30 kg/m2; 2) The patient is awake before surgery, with intravenous general anesthesia with spontaneous breathing retained; 3) Preoperative American Association of Anesthesiology (ASA) grade I~II; 4) No serious heart, lung, brain and other important organs, and no obvious abnormalities in liver and kidney function; 5) Clearly understand the study content of this study and voluntarily participate in it, and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1) Patients with serious abnormal heart, lung, liver and kidney function or serious cardiovascular and cerebrovascular diseases; 2) People with a heart rate <55 beats / min or a high degree of atrioventricular block requiring pacemaker installation; 3) Patients with sinus tachycardia or severe arrhythmia; 4) Patients with hypotension, shock or hypertension grade 2 or above; 5) Patients known to be allergic to the anesthetic drugs used in the institute or with a history of severe allergies; 6) Patients with long-term use of nonsteroidal anti-inflammatory drugs, narcotic analgesics or sedatives; 7) People with mental system diseases (schizophrenia, mania, confusion, etc.), long-term history of psychotropic drugs and cognitive dysfunction; 8) No serious adverse events occurred during the study or unexpected events; 9) Patients with severe respiratory lesions (obstructive sleep apnea syndrome, acute respiratory tract infection, acute onset of chronic obstructive pulmonary disease, uncontrolled asthma, etc.) or myasthenia gravis 10) Participated in any clinical trial as a subject in the last 3 months; 11) Patients who are not considered appropriate by the investigator to participate in the trial;

Design outcomes

Primary

MeasureTime frame
mean arterial pressure ;heart rate ;oxygen saturation of blood SPO2;median effective dose ED50;

Secondary

MeasureTime frame
bispectral index BIS;noxious index NOX;median effective dose 95 ED95;Modified Observer’s Assessment of Alert MOAA/S;

Countries

China

Contacts

Public ContactNa-Liang

Nanhua Hospital affiliated to Nanhua University

994428583@qq.com+86 152 0072 4385

Outcome results

None listed

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