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The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill Adults.

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ClinicalTrials.gov Identifier: NCT02123589
Recruitment Status : Unknown
Verified April 2014 by Kangyan, West China Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 25, 2014
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
Kangyan, West China Hospital

Brief Summary:
The study was designed to explore the effects of different sedation protocol on incidence rates of delirium and PTSD in severe patients with mechanically ventilation.

Condition or disease Intervention/treatment Phase
Sedative Withdrawal Delirium Drug: Deep sedation(midazolam and fentanyl ) Drug: Deep and daily interruption of sedation(midazolam and fentanyl ) Drug: Light sedation(midazolam and fentanyl ) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill adults-a Prospective, Randomized and Controlled Trial
Study Start Date : April 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Deep sedation
Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -5 and -3
Drug: Deep sedation(midazolam and fentanyl )
0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl,continuous intravenous infusion ; the target level of sedation,RASS score between -5 and -3

Experimental: Deep and daily interruption of sedation
Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -5 and -3.and from the second day after subject was admitted in ICU, daily interruption of sedation will be taken .
Drug: Deep and daily interruption of sedation(midazolam and fentanyl )
0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl continuous intravenous infusion ; The target level of sedation,RASS score between -5 and -3. Daily interruption of sedation will be taken from the second day after admitted in ICU

Experimental: Light sedation
Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -2 and +1.
Drug: Light sedation(midazolam and fentanyl )
0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl,continuous intravenous infusion ; The target level of sedation,RASS score between -2 and +1;




Primary Outcome Measures :
  1. The incident rate of delirium [ Time Frame: From weaning to discharged from ICU,about 7 days. ]
  2. The incident rates of PTSD [ Time Frame: 30th day and 180th day after discharged from ICU ]
  3. The duration of delirium [ Time Frame: From weaning to discharged from ICU,about 7 days. ]

Secondary Outcome Measures :
  1. Incidence rate of unexpected extubation [ Time Frame: From intubation to weaning,about 7 days ]
  2. Dosage of analgesics and sedatives [ Time Frame: From intination of analgesics and sedatives to stopping drug appication,about 7 days ]
  3. The duration of mechanical ventilation [ Time Frame: From intubation to weaning,about 7days ]
  4. Duration of ICU [ Time Frame: From admitted to ICU to discharged from ICU,about 7 days ]
  5. The whole hospitalization time [ Time Frame: From admitted to hospital to discharged from hospital,about 7 days ]
  6. Patients' death rates within ICU stay [ Time Frame: From admitted to ICU to discharged from ICU,about 7 days ]
  7. Patients' death rates within hospitalized stay [ Time Frame: From admitted to hospital to discharged from hospital,about 7 days ]
  8. The cost in ICU [ Time Frame: From admitted to ICU to discharged from ICU,about 7 days ]
  9. The total cost in hospital [ Time Frame: From admitted to hospital to discharged from hospital,about 7 days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Critically ill adults whose expected time of mechanical ventilation is longer than 24 hours
  • Aged between 18 years old to 85 years old.

Exclusion Criteria:

  • Subjects with brain injury;
  • History of cardiopulmonary resuscitation;
  • Mental disability;
  • Taken neuromuscular blocking drugs;
  • Inability to exchange;
  • Contraindicated to midazolam or morphine;
  • Inconvenience to daily interruption

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Responsible Party: Kangyan, Physician, West China Hospital
ClinicalTrials.gov Identifier: NCT02123589    
Other Study ID Numbers: West ChinaH Sedation
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Delirium
Critical Illness
Disease Attributes
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Fentanyl
Midazolam
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents