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Efficacy and safety of remazolam toluene sulfonate in sedation of ECMO patients

Efficacy and safety of remazolam toluene sulfonate in sedation of ECMO patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094871
Enrollment
Unknown
Registered
2024-12-30
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

respiratory failure

Interventions

Experimental group:Remazolam toluenesulfonate was injected intravenously to sedation

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age over 18 years old, gender unlimited; 2.ECMO treatment is required in ICU; 3. 18 kg/m^2 <=BMI<= 30 kg/m^2; 4. Clearly understand and voluntarily participate in this study.

Exclusion criteria

Exclusion criteria: 1.Patients who are expected to die within 48 hours; 2.Previous history of brain injury; 3. The condition requires deep sedation or does not require continuous sedation; 4. Alzheimer's disease; 5. Patients with advanced malignant tumors; 6. palliative care providers; 7. History of alcohol abuse or drug abuse; 8. Patients with severe hepatic and renal insufficiency (creatinine higher than 2mg/l, liver enzymes increased more than 4 times or jaundice); 9. Patients with recent seizures (within 3 months); 10. People who have serious listening difficulties and cannot communicate; 11. Have participated in other clinical trials; 12.Pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
the time within the target range of RASS accounts for 70% of the study drug administration time without other rescue treatment;

Secondary

MeasureTime frame
the rate of delirium;Proportion of patients treated with sedative medication;The time it takes for consciousness to fully regain after sedation is stopped;Incidence of adverse events;ICU case fatality rate;Dose of sedative and analgesic medication;Duration in the ICU;Total hospitalization costs and sedation and analgesia-related expenses;

Countries

China

Contacts

Public ContactJinyan Xing

The Affiliated Hospital of Qingdao University

xingjy-1@163.com+86 135 5301 4896

Outcome results

None listed

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