Clinical trial NCT02117726: Impact of Various Sedation Regimens on the Incidence of Delirium
Official title: Impact of Various Sedation Regimens on the Incidence of Post-sedation Delirium in Patients Receiving Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Delirium
Keywords: Sedation;
ARDS;
Mechanical ventilation
Hypnotics
Antianxiety Drugs
Causing
Adverse Effects
Therapeutic Use
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2014-04-21
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


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 outcomes:
measure: Incidence rates and duration of delirium
timeFrame: up to 15 days
measure: Sedation interruption
timeFrame: up to 5 days
Secondary outcomes:
measure: Sedation therapy effect
timeFrame: up to 7 days
measure: Hospitalized days in ICU
timeFrame: up to 15 days
measure: Death rates
timeFrame: 28 days
measure: Incidence rate of patients self-extubation
timeFrame: up to 7 days
measure: Injection speed, total dose and injection of sedatives in different groups.
timeFrame: 7 days
measure: Additional dose of fentanyl and midazolam
timeFrame: up to 7 days
measure: Dosage of diuretic, antiemetic, hypoglycemic, beta-receptor antagonist and vasoactive agents.
timeFrame: up to 15 days
measure: Variation degree of HR, RR, BP and SpO2
timeFrame: up to 15 days
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: HeNan Tumor Hospital
state: Henan
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Weifang
country: China
facility: Affiliated Hospital of Weifang Medical University
state: Shandong
city: Zibo
country: China
facility: Central Hospital of Zibo
state: Shandong
Study officials:
References: