Back to resultsThe Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill Adults.
Primary Purpose
Sedative Withdrawal Delirium
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Deep sedation(midazolam and fentanyl )
Deep and daily interruption of sedation(midazolam and fentanyl )
Light sedation(midazolam and fentanyl )
Sponsored by
About this trial
This is an interventional prevention trial for Sedative Withdrawal Delirium
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Deep sedation
Deep and daily interruption of sedation
Light sedation
Arm Description
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
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 .
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.
Outcomes
Primary Outcome Measures
The incident rate of delirium
The incident rates of PTSD
The duration of delirium
Secondary Outcome Measures
Incidence rate of unexpected extubation
Dosage of analgesics and sedatives
The duration of mechanical ventilation
Duration of ICU
The whole hospitalization time
Patients' death rates within ICU stay
Patients' death rates within hospitalized stay
The cost in ICU
The total cost in hospital
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02123589
Brief Title
The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill Adults.
Official Title
The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill adults-a Prospective, Randomized and Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedative Withdrawal Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deep sedation
Arm Type
Experimental
Arm Description
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
Arm Title
Deep and daily interruption of sedation
Arm Type
Experimental
Arm Description
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 .
Arm Title
Light sedation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Deep sedation(midazolam and fentanyl )
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Deep and daily interruption of sedation(midazolam and fentanyl )
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Light sedation(midazolam and fentanyl )
Intervention Description
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 Measure Information:
Title
The incident rate of delirium
Time Frame
From weaning to discharged from ICU,about 7 days.
Title
The incident rates of PTSD
Time Frame
30th day and 180th day after discharged from ICU
Title
The duration of delirium
Time Frame
From weaning to discharged from ICU,about 7 days.
Secondary Outcome Measure Information:
Title
Incidence rate of unexpected extubation
Time Frame
From intubation to weaning,about 7 days
Title
Dosage of analgesics and sedatives
Time Frame
From intination of analgesics and sedatives to stopping drug appication,about 7 days
Title
The duration of mechanical ventilation
Time Frame
From intubation to weaning,about 7days
Title
Duration of ICU
Time Frame
From admitted to ICU to discharged from ICU,about 7 days
Title
The whole hospitalization time
Time Frame
From admitted to hospital to discharged from hospital,about 7 days
Title
Patients' death rates within ICU stay
Time Frame
From admitted to ICU to discharged from ICU,about 7 days
Title
Patients' death rates within hospitalized stay
Time Frame
From admitted to hospital to discharged from hospital,about 7 days
Title
The cost in ICU
Time Frame
From admitted to ICU to discharged from ICU,about 7 days
Title
The total cost in hospital
Time Frame
From admitted to hospital to discharged from hospital,about 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill Adults.
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