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Application of different doses of remimazolam besylate in hysteroscopic surgery

Application of different doses of remimazolam besylate in hysteroscopic surgery: a single-center, prospective, randomized, double-blind, parallel-controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041690
Enrollment
Unknown
Registered
2021-01-01
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

hysteroscopy

Interventions

A:The initial loading dose of remimazolam besylate was 7mg
B:The initial loading dose of remimazolam besylate was 9.5mg
C:The initial loading dose of remimazolam besylate was 12mg
D:The initial loading dose of remimazolam besylate was 14.5mg

Sponsors

Shenzhen Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective hysteroscopic surgery (level 1-2 surgery); 2. BMI: 20 to 25 kg/m2; 3. ASA I - II; 4. Agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1.Benzodiazepines or opioids are taken daily or intermittently for the last 1 month or 3 months; 2.Pregnancy or lactation;Patients with obvious respiratory and circulatory dysfunction, abnormal blood routine, blood 3.biochemistry and blood coagulation function preoperative; 4.Patients with severe neuropsychiatric disease; 5.Allergic or contraindicated to benzodiazepines, opioids, flumazine, naloxone and other drugs and their components; 6.Patients with myasthenia gravis; 7.Patients with modified Mallampati score >= III or with other respiratory management difficulties.

Design outcomes

Primary

MeasureTime frame
Success rate of subjects with MOAA/S score <= 3 points after giving the first trial drug;

Secondary

MeasureTime frame
MOAA/S score of subjects at each observation time point;The time begin the operation after the first trial drug was given ;The frequency and dose of remimazolam besylate were added;Adverse event occurrence;if injection pain happen;The time from the end of the last dose until the human subject wakes up;The time from the end of the last administration until the human subject meets the criteria for withdrawal;The situation and dose of flumazine;

Countries

China

Contacts

Public ContactDaili Chen

Shenzhen Maternity and Child Healthcare Hospital

happy-99@163.com+86 13500052565

Outcome results

None listed

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