Remimazolam Besylate in Mechanically Ventilated ICU Patients

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Propofol; Remifentanil

Criteria

Inclusion Criteria:

• Patients aged >= 18 and <= 75 years;

• Endotracheal intubated;

• Patients expected to be mechanically ventilated >= 24h;

• Demand for light/moderate sedation (a RASS score of -3 to 0).

Exclusion Criteria:

• Pregnant;

• Lactant;

• Severe central nervous system disease (massive cerebral infarction/hemorrhage; status epilepticus; severe dementia, etc.);

• Acute hepatitis;

• Severe liver disease (Child-Pugh C);

• Chronic kidney disease (CKD grade 3 above);

• Unstable angina pectoris or acute myocardial infarction;

• Left ventricular ejection fraction <= 30%;

• Heart rate < 50bpm;

• Type 2 second-degree or third-degree atrioventricular block (except those implanted a pacemaker);

• Two vasoconstrictors are used to maintain SBP above 90mmHg after sufficient fluid resuscitation;

• Acute glaucoma

• Myasthenia gravis;

• Alcohol or drug withdrawa;

• Psychopath

• Near death;

• Allergic to remimazolam, propofol, benzodiazepines or its excipients (lactose/dextrin 40); lipid emulsion; or other diseases (such as pancreatitis associated with hyperlipidemia) for which lipid emulsion should not be used;

• Informed Consent is unsigned.