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Study on the effectiveness and safety of remazolam tosylate for sedation in mechanically ventilated ICU patients

Study on the effectiveness and safety of remazolam tosylate for sedation in mechanically ventilated ICU patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049067
Enrollment
Unknown
Registered
2021-07-20
Start date
2021-08-10
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Mechanically ventilated patients

Interventions

Sponsors

Henan Provincial People`s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years; 2. BMI is 18kg/m2-28kg/m2; 3. The expected mechanical (tracheal intubation) ventilation time in the ICU is more than 24 hours; 4. Estimated ICU hospitalization time >= 48 hours; 5. Patients or their family members voluntarily participated in this study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding; 2. Have a history of alcohol or drug abuse, mental illness or severe cognitive impairment; 3. Severe chronic liver disease (Child-Pugh grade B or C); 4. Bradycardia (II/III degree atrioventricular block), right bundle branch block; 5. Acute myocardial infarction or severe heart failure (NYHA class IV); 6. Patients allergic to remazolam tosylate; 7. Myasthenia gravis patients, coma (GCS score <= 8 points); 8. Participate in clinical trials of other drugs.

Design outcomes

Primary

MeasureTime frame
Rate of achieving sedation goals with a single medication and other indicators;

Secondary

MeasureTime frame
duration of ICU stay?duration of Mechanical ventilation and other indicators;

Countries

China

Contacts

Public ContactQin Bingyu

Henan Provincial People's Hospital

nicolasby@126.com+86 13633810677

Outcome results

None listed

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