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Study on the safety and efficacy of rimazolam benzenesulfonate in hysteroscopy

Study on the safety and efficacy of rimazolam benzenesulfonate in hysteroscopy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038252
Enrollment
Unknown
Registered
2020-09-15
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-12-07

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

Conditions

Abnormal uterine bleeding

Interventions

Remimazolam group (group R):Pump rimazolam
Propofol group (P group):Pump propofol

Sponsors

The First People's Hospital of Mengcheng County
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The subjects voluntarily participated and signed the informed consent; 2. Subjects aged 18-65 years old; 3. The subjects were classified as I-II by ASA; 4. Subjects with body mass index (BMI) of 19-30 kg / m2; 5. Patients scheduled for hysteroscopy.

Exclusion criteria

Exclusion criteria: 1. Those who have history of alcoholism or allergy to general anesthesia drugs; 2. Emergency patients or patients with acute inflammation; 3. Patients with impaired liver or kidney function; 4. Dementia patients or severe cognitive impairment; 5. Any Subject of communication difficulties; 6. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
MOAA/S score;Ramsay score;Recovery time of the patient (time from the end of the operation to the time of opening the eyes);The number of patients with SpO2 < 90%;

Secondary

MeasureTime frame
The changes of systolic blood pressure, diastolic blood pressure, heart rate, moaA / s score and SpO2 were observed and recorded before anesthesia (T0), 2 minutes after anesthesia (T1), at the time of cervical dilatation (T2), at the end of operation (T3) and at the time of recovery (T4);;The visual analogue scale (VAS) of lower abdominal pain was recorded immediately after awake and 15 min, 30 min, 1 h, 2 h and 6 h after operation;The number of patients using ephedrine and atropine in each group was recorded;

Countries

China

Contacts

Public ContactXiaoqiang Zhang

Mengcheng First People's Hospital

zxqhl@126.com+86 13309670321

Outcome results

None listed

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