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A Study on the Sedative Effects of Remimazolam Sodium Benzoate Combined with Different Analgesics in Hysteroscopic Surgery

A Study on the Sedative Effects of Remimazolam Sodium Benzoate Combined with Different Analgesics in Hysteroscopic Surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087504
Enrollment
Unknown
Registered
2024-07-29
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Endometrial glandular hyperplasia

Interventions

Group A:Remazolam besylate combined with afentanil, initial dose of afentanil 0.5mg(5ml), fractional addition of afentanil 0.25mg(2.5ml), not more than 1mg(10ml).
Group S:Remazolam besylate combined with Sufentanil, initial dose of sufentanil 5µg(5ml), sufentanil 2.5µg(2.5ml), not more than 10µg(10 mL).
Group F:Remazolam besylate combined with fentanyl, initial dose of fentanyl 0.05mg(5ml), fractional addition of fentanyl 0.025mg(2.5ml), not more than 0.1mg(10ml).
Group B:Remazolam besylate combined with butorphanol, initial dose of butorphanol 0.5mg(5ml), plus butorphanol 0.25mg in batches, not more than 1mg(10ml).

Sponsors

Dongyang Women and Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists (ASA) Grade I to II; Age 18 ~ 60 years old; BMI 18 ~ 28?/m2, patients with hysteroscopic surgery.

Exclusion criteria

Exclusion criteria: ? History of mental illness; History of asthma; History of neurological disorders; People who are allergic to multiple foods or drugs; People with known allergies to benzodiazepines and opioids; ? Anemia: hemoglobin =90g/L; ? History of chronic pain; A long history of opioid use; Drug addicts and alcoholics; ? Patients with severe heart disease; Patients with severe hypertension and arrhythmia; Preoperative systolic blood pressure > 180mmHg and/or diastolic blood pressure > 110mmHg; ? Abnormal physiological states such as lactation.

Design outcomes

Primary

MeasureTime frame
The effect of anesthesia during operation;Recovery time;Incidence of adverse reactions;

Secondary

MeasureTime frame
Blood pressure;Heart rate;Blood oxygen saturation;MOAA/S score;satisfaction;VAS score;SCI score;

Countries

China

Contacts

Public ContactYingchun Shi

Dongyang Women and Children's Hospital

13957969752@163.com+86 139 5796 9752

Outcome results

None listed

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