Comparison of sedative effect and prognosis between remimazolam toluenesulfonate and propofol in ICU patients with mechanical ventilation: a prospective, randomized, single-center clinical study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080234

Enrollment

Unknown

Registered

2024-01-24

Start date

2024-01-24

Completion date

Unknown

Last updated

2024-01-28

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

Conditions

ICU patients with mechanical ventilation

Interventions

Intervention Group :remimazolam toluenesulfonate

Control Group:Propofol

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 18 years old = Age = 80 years old; Patients requiring invasive mechanical ventilation; Anticipated mechanical ventilation duration = 24 hours; Willingness to provide informed consent and participate in the study.

Exclusion criteria

Exclusion criteria: Long-term use of benzodiazepines or psychotropic medications; Patients with substance abuse, alcohol dependence, mental disorders, or consciousness disorders; Patients with conditions indicating prolonged mechanical ventilation, such as peripheral neuromuscular diseases, brainstem respiratory center involvement, difficulty weaning in chronic obstructive pulmonary disease, etc.; Patients requiring deep sedation to maintain a Richmond Agitation-Sedation Scale (RASS) score of <-2, including those with oxygenation index = 100, those receiving neuromuscular blockade requiring loss of consciousness, patients with status epilepticus, cases requiring absolute immobilization due to surgical or clinical conditions, severe traumatic brain injury with intracranial hypertension, therapeutic hypothermia, and other clinical assessments; Pregnant or lactating women; Known allergy to the study drug or other contraindications; Patients currently participating in other drug or clinical trials or unwilling to provide informed consent.

Design outcomes

Primary

Measure	Time frame
Sedation Achievement Rate (indicating the proportion of patients achieving sedation and analgesia goals without the need for combination therapy);Sedation Achievement Time (hour);	—

Secondary

Measure	Time frame
Mechanical Ventilation Days;ICU Length of Stay;28-Day Mortality Rate;	—

Countries

China

Contacts

Public ContactZhen-jie Hu; Cong-cong Zhao

The Fourth Hospital of Hebei Medical University

syicuhzj@163.com+86 139 3385 6908

Outcome results

None listed

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