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Efficacy and safety of remimazolam tosylate for sedation management in elderly orthopedic patients with acute agitation

Efficacy and safety of remimazolam tosylate for sedation management in elderly orthopedic patients with acute agitation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036101
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-10-26

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

Conditions

Perioperative agitation

Interventions

trial group:Sedation management with remimazolam
control group:Sedation management with dexmedetomidine

Sponsors

Sichuan Provincial Orthopedic Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients who have been removed endotracheal tube after fracture surgery and admitted to ICU for monitoring and treatment; 2. Aged >= 60 years, male or female; 3. Agitation-Sedation Scale (RASS) >= 1 point during ICU stay; 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Have a history of mental illness, or long-term use of sedative drugs, antipsychotic drugs and alcohol dependence; 2. Combined with craniocerebral trauma or intracranial diseases; 3. Severe allergic constitution, immune dysfunction or defects, or allergic to the drugs used in the program; 4. Combined or postoperative complications of severe cardiac dysfunction, severe liver and kidney dysfunction or severe obstructive pulmonary disease; 5. Combined with visual impairment, hearing impairment and other inability to communicate normally; 6. Patients who are currently participating in other drug studies.

Design outcomes

Primary

MeasureTime frame
Time to reach sedation target;Time to control agitation;

Secondary

MeasureTime frame
RASS scores before and after sedation;Use of sedative drugs;Incidence of delirium after agitation control;Total hospital stay;Duration of ICU stay;Hospital infection rate;Incidence of deep venous thrombosis;

Countries

China

Contacts

Public ContactQin Zhijun

Sichuan Provincial Orthopedic Hospital

qin18716111836@126.com+86 18728179291

Outcome results

None listed

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