Delirium
Conditions
Keywords
Sedation;, ARDS;, Mechanical ventilation, Hypnotics, Antianxiety Drugs, Causing, Adverse Effects, Therapeutic Use
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 .
Interventions
DRUGPropofol,midazolam
Sponsors
Shandong Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rates and duration of delirium | up to 15 days | Incidence rates and duration of delirium within 14 days after initiation of sedation with dexmedetomidine or propofol |
| Sedation interruption | up to 5 days | Eye opening according to the voice orders, eye tracking, clenching fist and nodding are involved in assessment, patients could do 3 of those or more is deemed as conscious and taken in delirium assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death rates | 28 days | Patients' death rates with a follow-up of 28 days |
| Incidence rate of patients self-extubation | up to 7 days | — |
| Injection speed, total dose and injection of sedatives in different groups. | 7 days | — |
| Sedation therapy effect | up to 7 days | The frequency of assessment whose score fall within the target range. |
| Dosage of diuretic, antiemetic, hypoglycemic, beta-receptor antagonist and vasoactive agents. | up to 15 days | — |
| Variation degree of HR, RR, BP and SpO2 | up to 15 days | — |
| Additional dose of fentanyl and midazolam | up to 7 days | — |
| Hospitalized days in ICU | up to 15 days | — |
Countries
China
Outcome results
None listed