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Impact of Remimazolam Besylate on Clinical Outcomes and Stress Response in ICU Patients Undergoing Mechanical Ventilation Bundle Treatment

Efficacy and Safety of Remimazolam Besylate in Bundle Therapy for Mechanically Ventilated Patients in the ICU: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123386
Enrollment
Unknown
Registered
2026-04-26
Start date
2025-02-20
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Critically ill patients requiring bundle therapy for mechanical ventilation

Interventions

Experimental Group:Remimazolam besylate is administered for sedation therapy
Control Group:Midazolam Injection is administered for sedation

Sponsors

second hospital of shanxi medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age >=18 years old; 2.Clinically requiring receipt of bundle therapy for mechanical ventilation for a duration of >= 3 days; 3.The patient voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with cerebrovascular sequelae or cognitive impairment who are unable to communicate; 2.Patients allergic to sedative and analgesic drugs; 3.Pregnant and lactating women; 4.Patients with second or third degree atrioventricular block those in the acute stage of myocardial infarction those with severe bradycardia those with left ventricular ejection fraction < 0.30; 5.Hemodynamically unstable patients patients with liver dysfunction classified as Child-Pugh Class C 6.those unable to cooperate with the research.

Design outcomes

Primary

MeasureTime frame
delirium;Richmond Agitation-Sedation Scale Score?Visual Analogue Scale Score;Duration of Mechanical Ventilation?Time to Extubation;

Secondary

MeasureTime frame
Clinical Hemodynamic Indicators;adverse event;

Countries

China

Contacts

Public Contactwangxiaoru

second hospital of shanxi medical university

Woxinpingjing@qq.com+86 351 3365 2531

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026