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

Study Overview
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Brief Summary
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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.

Official Title
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The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill adults-a Prospective, Randomized and Controlled Trial

Conditions
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Sedative Withdrawal Delirium

Intervention / Treatment
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* Drug: Deep sedation(midazolam and fentanyl )
* Drug: Deep and daily interruption of sedation(midazolam and fentanyl )
* Drug: Light sedation(midazolam and fentanyl )


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep sedation<br>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 )<br>* 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<br>|
| Experimental: Deep and daily interruption of sedation<br>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 )<br>* 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<br>|
| Experimental: Light sedation<br>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 )<br>* 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;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incident rate of delirium |  | From weaning to discharged from ICU,about 7 days. | 
| The incident rates of PTSD |  | 30th day and 180th day after discharged from ICU | 
| The duration of delirium |  | From weaning to discharged from ICU,about 7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of unexpected extubation |  | From intubation to weaning,about 7 days | 
| Dosage of analgesics and sedatives |  | From intination of analgesics and sedatives to stopping drug appication,about 7 days | 
| The duration of mechanical ventilation |  | From intubation to weaning,about 7days | 
| Duration of ICU |  | From admitted to ICU to discharged from ICU,about 7 days | 
| The whole hospitalization time |  | From admitted to hospital to discharged from hospital,about 7 days | 
| Patients' death rates within ICU stay |  | From admitted to ICU to discharged from ICU,about 7 days | 
| Patients' death rates within hospitalized stay |  | From admitted to hospital to discharged from hospital,about 7 days | 
| The cost in ICU |  | From admitted to ICU to discharged from ICU,about 7 days | 
| The total cost in hospital |  | From admitted to hospital to discharged from hospital,about 7 days |