Impact of Various Sedation Regimens on the Incidence of Delirium

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Sedation drugs that are commonly used in ICU in treatment of ARDS, includes propofol, midazolam and dexmedetomidine . Among these, both dexmedetomidine and propofol have been reported to be used together with midazolam in ICU and the combination of propofol and midazolam is most commonly used, but things follow include a high incidence rate of delirium, But the combination of midazolam and dexmedetomidine may have complementary advantages and could have be a better choice for sedation. In this study, we attempted to observe the effects of two different drug regimens on delirium incidence rates in severe ARDS patients' : midazolam and propofol vs propofol and dexmedetomidine .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Provincial Hospital
• Treatments: Dexmedetomidine; Midazolam; Propofol

Criteria

Inclusion Criteria:

• Subjects willing to give written informed consent.

• Mild, moderate or severe ARDS patients demanding invasive mechanical ventilation.

• Subjects whose expected time of mechanical ventilation is longer than 24 hours.

• Subjects aged between 18 and 70.

Exclusion Criteria:

• Subjects with extremely unstable circulation, whose SBP lower than 90mmHg after volume expansion or pressor agent treatment.

• Subjects with extremely unstable circulation, whose SBP lower than 90mmHg after volume expansion or pressor agent treatment.

• Subjects with heart rates less than 50 beats per minute.

• Subjects with second or third degree atrioventricular block.

• Subjects with serious cerebral injury, severe neurologic disorder (e.g acute stroke, uncontrolled epilepsy and severe dementia) or coma.

• Subjects with acute or severe liver disease (Child-Pugh class C), see attachment 2.

• ARDS patients caused by pulmonary fibrosis or COPD.

• Subjects on all types hemodialysis.

• Subjects with neuromuscular system disease, alcohol withdrawal syndrome or mental disease before entrance of ICU.

• Subjects suspected of narcotic analgesics abusing.

• Subjects needing neuromuscular blocking agents (except intubation).

• Subjects allergic to investigational products or with other contraindication.

• Subjects who are breastfeeding or pregnant

• Subjects participated in other study within 30 days before entrance of ICU