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A prospective, single-center, double-blind, randomized controlled study on the efficacy and safety of remimazolam tosylate versus propofol in sedation in patients with sepsis requiring mechanical ventilation.

A prospective, single-center, double-blind, randomized controlled study on the efficacy and safety of remimazolam tosylate versus propofol in sedation in patients with sepsis requiring mechanical ventilation.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082605
Enrollment
Unknown
Registered
2024-04-01
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

sepsis

Interventions

Control group:Propofol plus Fentanyl
Intervention Group:Remimazolam Tosilate plus Fentanyl

Sponsors

Taizhou Hospital of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Adult patients aged 18 to 75 years old. (2) Diagnosed with sepsis, meeting the following criteria: ? Presence of infection, ? Sequential Organ Failure Assessment (SOFA) score increased by 2 or more points. (3) Initial endotracheal intubation requiring clinical sedation, with an anticipated need for at least 24 hours of mechanical ventilation. (4) Informed consent obtained from the patient prior to the start of the study.

Exclusion criteria

Exclusion criteria: (1) Severe chronic liver disease (Child-Pugh class B or C). (2) Presence of acute myocardial infarction, severe bradycardia (heart rate < 50 beats per minute), second- or third-degree atrioventricular block. (3) Mental disorders (such as schizophrenia, depression), cognitive impairment, epilepsy, history of substance abuse with psychotropic or anesthetic drugs. (4) Diseases requiring deep sedation (Richmond Agitation-Sedation Scale [RASS] score -4 to -5). (5) Patients receiving sedation due to non-tolerant factors of the ventilator (such as epilepsy). (6) Already or expected to cease treatment due to poor prognosis. (7) Loss of hearing or vision, or any other condition that would significantly interfere with the collection of study data. (8) Pregnant or lactating women. (9) Allergy to Remifentanil or propofol. (10) Any other condition deemed by the investigator to be detrimental to the subject.

Design outcomes

Primary

MeasureTime frame
the percentage of time within the target sedation range without rescue sedation;

Secondary

MeasureTime frame
length of stay in the ICU;Time required to first reach target sedation range;ventilator-free days within 14 days;Incidence of delirium; incidence of cardiovascular adverse events;

Countries

China

Contacts

Public Contactzhang sheng

Taizhou Hospital of Zhejiang Province

zhangs@enzemed.com+86 136 7665 5525

Outcome results

None listed

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