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Effective Dose of Remimazolam Besylate for Sedation in Postoperative Mechanically Ventilated ICU Patients Undergoing Noncardiac Surgery

Effective Dose of Remimazolam Besylate for Sedation in Postoperative Mechanically Ventilated ICU Patients Undergoing Noncardiac Surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039343
Enrollment
Unknown
Registered
2020-10-24
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

ICU agitation

Interventions

Trial Group 1:Remimazolam 0.5mg/kg/h
Trial Group 2:Remimazolam 1mg/kg/h
Trial Group 3:Remimazolam 1.5mg/kg/h
Trial Group 4:Remimazolam 2mg/kg/h
Trial Group 5:Remimazolam 2.5mg/kg/h
Trial Group 6:Remimazolam 3mg/kg/h

Sponsors

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged > 18 and = 8h and < 24h.

Exclusion criteria

Exclusion criteria: 1. Included in this study previously; 2. Pregnant; 3. Lactant; 4. Severe central nervous system disease (massive cerebral infarction/hemorrhage; status epilepticus; severe dementia, etc.); 5. Acute hepatitis; 6. The operation is kidney transplantation; 7. The operation is liver transplantation; 8. The operation is brain surgery (except interventional embolization of the aneurysm); 9. Impossible to follow doctor's order due to brain trauma before the operation; 10. Severe liver disease (Child-Pugh C); 11. Chronic kidney disease (CKD grade 3 above); 12. Myasthenia gravis; 13. Allergic to benzodiazepines or its excipients (lactose/dextrin 40); 14. Unstable angina pectoris or acute myocardial infarction; 15. Left ventricular ejection fraction 15ug/kg/min or epinephrine > 0.2ug/kg/min or norepinephrine > 0.2ug/kg/min) are used to maintain SBP above 90mmHg after sufficient fluid resuscitation; 19. Acute glaucoma; 20. Alcohol or drug withdrawal; 21. Psychopath.

Design outcomes

Primary

MeasureTime frame
Effective dose of remimazolam besylate for sedation;

Secondary

MeasureTime frame
Effects on patients' circulation;

Countries

China

Contacts

Public ContactYou Shang

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

you_shanghust@163.com+86 15972127819

Outcome results

None listed

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