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Efficacy and safety analysis of remazolam toluenesulfonate for vertebroplasty in elderly patients

Efficacy and safety analysis of remazolam toluenesulfonate for vertebroplasty in elderly patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099227
Enrollment
Unknown
Registered
2025-03-20
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Vertebroplasty

Interventions

Experimental group:Sufentanil citrate injection 0.1µg/kg and Remazolam toluenesulfonate 0.2mg/ kg were injected intravenously before the operation. Remazolam toluenesulfonate was injected intravenousl
Control group:Sufentanil citrate injection 0.1µg/kg was injected intravenously before the operation, 0.9% sodium chloride injection of the same ml was injected intravenously in the experimental group,

Sponsors

Jintang County first People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Age 60-90 years old, BMI (18.5-30kg/m^2); (2) Elective vertebroplasty surgery, anesthesia method: local infiltration anesthesia; (3) Clear, no mental disorder, intellectual disability and other diseases; (4) ASA classification: I-III. grades; Cardiac function: Grades 1-3.

Exclusion criteria

Exclusion criteria: (1) Combined with heart, lung and other vital organ failure; (2) Combined with acute and chronic systemic infection; (3) Those with a history of long-term antipsychotic medication, severe depression, and myasthenia gravis; (4) Allergy to the drugs used in this study; (5) Patients who are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Mean blood pressure;Heart rate;Pulse oxygen saturation;RASS sedative agitation score;

Secondary

MeasureTime frame
Incidence of intraoperative hypotension;Incidence of respiratory depression;Incidence of severe bradycardia(< 50 times /min);Incidence of low oxygen saturation (SpO2 < 90%);

Countries

China

Contacts

Public ContactQu Yang

Jintang County first People's Hospital

1452989137@qq.com+86 178 2810 1220

Outcome results

None listed

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