Impact of Various Sedation Regimens on the Incidence of Delirium
NCT ID: NCT02117726
Last Updated: 2014-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
320 participants
INTERVENTIONAL
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dexmedetomidine,midazolam
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.
Dexmedetomidine,midazolam
Propofol,midazolam
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.
Propofol,midazolam
Interventions
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Dexmedetomidine,midazolam
Propofol,midazolam
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
Responsible Party
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Wangchunting
Director
Locations
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HeNan Tumor Hospital
Zhengzhou, Henan, China
The Second Hospital of Shandong University
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Liaocheng Hospital
Liaocheng, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Affiliated Hospital of Weifang Medical University
Weifang, Shandong, China
Central Hospital of Zibo
Zibo, Shandong, China
Countries
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Facility Contacts
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Other Identifiers
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ARDS2014
Identifier Type: -
Identifier Source: org_study_id
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