Impact of Various Sedation Regimens on the Incidence of Delirium
1 other identifier
interventional
320
1 country
7
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedJuly 16, 2014
July 1, 2014
1.6 years
April 16, 2014
July 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence rates and duration of delirium
Incidence rates and duration of delirium within 14 days after initiation of sedation with dexmedetomidine or propofol
up to 15 days
Sedation interruption
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.
up to 5 days
Secondary Outcomes (8)
Sedation therapy effect
up to 7 days
Hospitalized days in ICU
up to 15 days
Death rates
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
- +3 more secondary outcomes
Study Arms (2)
Dexmedetomidine,midazolam
EXPERIMENTALSlow 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.
Propofol,midazolam
ACTIVE COMPARATORSlow 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
HeNan Tumor Hospital
Zhengzhou, Henan, 450000, China
The Second Hospital of Shandong University
Jinan, Shandong, 250033, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000, China
Liaocheng Hospital
Liaocheng, Shandong, 252000, China
Linyi People's Hospital
Linyi, Shandong, 276000, China
Affiliated Hospital of Weifang Medical University
Weifang, Shandong, 261031, China
Central Hospital of Zibo
Zibo, Shandong, 255000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
April 16, 2014
First Posted
April 21, 2014
Study Start
May 1, 2014
Primary Completion
December 1, 2015
Last Updated
July 16, 2014
Record last verified: 2014-07