Impact of Various Sedation Regimens on the Incidence of Delirium

Shandong First Medical University

Status and phase: Unknown; Phase 4

Conditions: Delirium

Treatments: Drug: Dexmedetomidine,midazolam; Drug: Propofol,midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT02117726

ARDS2014

Details and patient eligibility

About

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 .

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

320 participants in 2 patient groups

Dexmedetomidine,midazolam

Experimental group

Description:

Slow injection of 2mg midazolam every minute and watching patients' reaction until attaining the target level of sedation;midazolam was maintained at 0.02\~0.1mg/kg/h, for 24 hours.Dexmedetomidine will be added at 0.2\~1.4μg/kg/h to maintain sedation.If target sedation level (RASS score) cannot be reached in maximum dose of dexmedetomidine, continuous intravenous infusion of midazolam could be used at 0.02\~0.1mg/kg/h, until the target level is reached.

Treatment:

Drug: Dexmedetomidine,midazolam

Propofol,midazolam

Active Comparator group

Description:

Slow injection of 2mg midazolam every minute and watching patients' reaction until attaining the target level of sedation;midazolam was maintained at 0.02\~0.1mg/kg/h, for 24 hours.Propofol will be added at 0.3\~4mg/kg/h to maintain sedation.If target sedation level (RASS score) cannot be reached in maximum dose of propofol, continuous intravenous infusion of midazolam could be used at 0.02\~0.1mg/kg/h, until the target level is reached.

Treatment:

Drug: Propofol,midazolam