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ClinicalTrials.gov ID

NCT02117726

Lead Sponsor

Shandong Provincial HospitalOTHER_GOV

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

320Estimated

Last Update Posted

Jul 16, 2014Estimated

Start Date

May 2014

Primary Completion Date

Dec 2015Estimated

Official Title

Impact of Various Sedation Regimens on the Incidence of Post-sedation Delirium in Patients Receiving Mechanical Ventilation

Brief 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 .

• Delirium

• Dexmedetomidine,midazolam
• Propofol,midazolam

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Shandong Provincial HospitalOTHER_GOV

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