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Study of effective doses of injectable rimazolam besylate for sedation of mechanically ventilated patients in the ICU after cardiac surgery

Study of effective doses of injectable rimazolam besylate for sedation of mechanically ventilated patients in the ICU after cardiac surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051513
Enrollment
Unknown
Registered
2021-09-25
Start date
2021-09-26
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

Post-operative cardiac surgery patients on mechanical ventilation

Interventions

Experimental group1:Remimazolam besylate 0.1mg/kg/h
Experimental group2:Remimazolam besylate 0.15mg/kg/h
Experimental group3:Remimazolam besylate 0.2mg/kg/h
Experimental group4:Remimazolam besylate 0.25mg/kg/h
Experimental group5:Remimazolam besylate 0.3mg/kg/h

Sponsors

Beijing Anzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. post-operative cardiac surgery mechanical ventilation requiring analgesic sedation and expected to require mechanical ventilation for >=12 hours and = 40%; 4. obtain informed consent from the patient or family.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding; 2. Severe, existing substantial liver disease with clinically significant portal hypertension, Child-Pugh C cirrhosis or acute liver failure; 3. Patients with acute and chronic renal insufficiency requiring dialysis; 4. Bronchial asthma or COPD, myasthenia gravis patients; 5. Patients with a history of alcohol or drug abuse; 6. Long-term oral sedative, anti-insomnia, anti-anxiety drugs 7. Patients who take long-term immunosuppressants or hormones; 8. There are symptoms of delirium and alcohol withdrawal; 9. Patients with severe pulmonary hypertension combined with Eisenmenger syndrome; 10. Circulatory or hemodynamic instability requires supporters of mechanical devices such as ECMO and IABP; 11. Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, status epilepticus; 12. Any condition that prevents the correct assessment of cognitive function, such as language and sensory disturbances or psychiatric disturbances (language difficulties or psychoorganic dysfunction); 13. Allergy to the research drug or other contraindications; 14. The patient himself or his legally authorized representative is unwilling to sign the informed consent; 15. There are factors that increase the risk associated with participating in the study (such as the presence of severe hypotension), which is not suitable for inclusion in the study according to the investigator's judgment.

Design outcomes

Primary

MeasureTime frame
Effective dose of remimazolam besylate for sedation of mechanically ventilated patients in the Intensive Care Unit after cardiac surgery;

Secondary

MeasureTime frame
Incidence of adverse cardiovascular events;

Countries

China

Contacts

Public ContactHou Xiaotong

Beijing Anzhen Hospital

xt.hou@ccmu.edu.cn+86 64456140

Outcome results

None listed

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