Skip to content

To determine ED50 and ED95 of remimazolam toluenesulfonate to induce auxiliary sedation in elderly patients undergoing spinal anesthesia

Clinical study on sedation of remimazolam during operation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051912
Enrollment
Unknown
Registered
2021-10-09
Start date
2021-10-10
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Anesthesia with electroresection of the prostate

Interventions

Sponsors

The Second Affiliated Hospital of Hainan Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Select elderly patients who have elective resection of the prostate at the Second Affiliated Hospital of Hainan Medical College; 2.ASA classification I~II; 3.Aged 65 to 85 years; 4.Sign the informed consent for anesthesia.

Exclusion criteria

Exclusion criteria: 1.Patients who are allergic to benzodiazepines and any components of this product; 2.Patients with myasthenia gravis; 3.Patients with schizophrenia and severe depression; 4.Pathological obesity/obstructive sleep apnea; 5.Acute upper respiratory tract infection; 6.Asthma attack period; 7.Uncontrolled severe hypertension; 8.Unstable angina; 9.Severe liver dysfunction; 10.Acute upper gastrointestinal bleeding with shock; 11.Severe anemia; 12.Gastrointestinal obstruction with retention of gastric contents; 13.Long-term sedative and analgesic drug use history and allergic history; 14.There are contraindications to anesthesia.

Design outcomes

Primary

MeasureTime frame
Modified Assessment of Alertness/Sedation;Mean arterial pressure;Heart Rate;Blood oxygen saturation;Consumption of medication dosage;Electroencephalogram Bispectral Index;The patient leaves the post-anesthesia monitoring treatment room;

Secondary

MeasureTime frame
The observation was stopped 24 hours after the telephone follow-up;

Countries

China

Contacts

Public ContactSun Hu

The Second Affiliated Hospital of Hainan Medical University

ztym0817@163.com+86 13617518996

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026