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Application of remimazolam besylate for sedation in elderly patients with invasive mechanical ventilation in ICU

Sedative effect of remimazolam besylate in elderly patients with invasive mechanical ventilation in ICU: a multicenter, prospective, randomized, controlled, single-blind, non-inferiority study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102878
Enrollment
Unknown
Registered
2025-05-21
Start date
2025-02-24
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None

Interventions

Control group:Propofol
Treatment group:Remimazolam besylate

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=65 years old; 2.Patients treated with invasive Mechanical Ventilation (excluding tracheotomy); 3.Patients with a sedation target RASS score of -2-0; 4.The duration of tracheal intubation on admission was =24 hours;

Exclusion criteria

Exclusion criteria: 1.High paraplegia, patients admitted to the ICU due to advanced malignancy or its complications; 2.Severe craniocerebral injury, brain tumor, intracranial hypertension, cerebrovascular accident, coma, status epilepticus, etc; 3.Patients with a history of alcohol or substance abuse; 4.High-dose vasoactive agents (norepinephrine >=0.8ug/kg*min) were needed to maintain hemodynamics after adequate fluid resuscitation; 5.Patients who were allergic to study drugs such as remimazolam besylate, propofol and their excipients; 6.Patients for whom informed consent was not obtained; 7.Participate in other clinical drug validation studies; 8.Patients with left ventricular ejection fraction <=40%; 9.Other conditions deemed by the investigator to be ineligible for inclusion;

Design outcomes

Primary

MeasureTime frame
During the treatment period, the time without intubation within 7 days in the two groups of patients;

Countries

China

Contacts

Public ContactZhenguo Zeng

The First Affiliated Hospital of Nanchang University

3489629107@qq.com+86 791 86427295

Outcome results

None listed

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