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Impact of Various Sedation Regimens on the Incidence of Delirium

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ClinicalTrials.gov Identifier: NCT02117726
Recruitment Status : Unknown
Verified July 2014 by Wangchunting, Shandong Provincial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 21, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Wangchunting, Shandong Provincial Hospital

Study Description
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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 .

Condition or disease Intervention/treatment Phase
Delirium Drug: Dexmedetomidine,midazolam Drug: Propofol,midazolam Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Various Sedation Regimens on the Incidence of Post-sedation Delirium in Patients Receiving Mechanical Ventilation
Study Start Date : May 2014
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Dexmedetomidine,midazolam
Active Comparator: 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.
 Drug: Propofol,midazolam


Outcome Measures
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Primary Outcome Measures :
  1. Incidence rates and duration of delirium [ Time Frame: up to 15 days ]
    Incidence rates and duration of delirium within 14 days after initiation of sedation with dexmedetomidine or propofol

  2. Sedation interruption [ Time Frame: 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 Outcome Measures :
  1. Sedation therapy effect [ Time Frame: up to 7 days ]
    The frequency of assessment whose score fall within the target range.

  2. Hospitalized days in ICU [ Time Frame: up to 15 days ]
  3. Death rates [ Time Frame: 28 days ]
    Patients' death rates with a follow-up of 28 days

  4. Incidence rate of patients self-extubation [ Time Frame: up to 7 days ]
  5. Injection speed, total dose and injection of sedatives in different groups. [ Time Frame: 7 days ]
  6. Additional dose of fentanyl and midazolam [ Time Frame: up to 7 days ]
  7. Dosage of diuretic, antiemetic, hypoglycemic, beta-receptor antagonist and vasoactive agents. [ Time Frame: up to 15 days ]
  8. Variation degree of HR, RR, BP and SpO2 [ Time Frame: up to 15 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117726


Locations
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China, Henan
HeNan Tumor Hospital Not yet recruiting
Zhengzhou, Henan, China, 450000
Contact: Fang Xing, physician    400-0371-818    xfsally2007@163.com   
Principal Investigator: Fang Xing, Physician         
China, Shandong
The Second Hospital of Shandong University Not yet recruiting
Jinan, Shandong, China, 250033
Contact: Chengen Ma    +86 15153169727    chengen99@163.com   
Affiliated Hospital of Jining Medical University Not yet recruiting
Jining, Shandong, China, 272000
Contact: Haiwei Yang, Physician    +86 13518675416    yhw200465@126.com   
Liaocheng Hospital Not yet recruiting
Liaocheng, Shandong, China, 252000
Contact: Tiejun Wu, physician    +86 13306352913    wtj0721@163.com   
Linyi People's Hospital Not yet recruiting
Linyi, Shandong, China, 276000
Contact: Tingfa Zhou    +86 13013538061    zhoutingfa66@126.com   
Affiliated Hospital of Weifang Medical University Not yet recruiting
Weifang, Shandong, China, 261031
Contact: Peirong Zhang, Physician    15269600599    zhangpeirong@csco.org.cn   
Central Hospital of Zibo Not yet recruiting
Zibo, Shandong, China, 255000
Contact: Shifu Wang, Physician    18678186866    wsficu@163.com   
Sponsors and Collaborators
Shandong Provincial Hospital
More Information
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Responsible Party: Wangchunting, Director, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT02117726     History of Changes
Other Study ID Numbers: ARDS2014
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Wangchunting, Shandong Provincial Hospital:
Sedation;
ARDS;
Mechanical ventilation
Hypnotics
 Antianxiety Drugs
Causing
Adverse Effects
Therapeutic Use
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Midazolam
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents