Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients

Study Overview
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Brief Summary
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This study was designed to observe the effects of dexmedetomidine on delirium and haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of dexmedetomidine.

Official Title
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Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients -a Single Center,Randomized and Controlled Trial

Conditions
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Safety of Dexmedetomidine Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Intensive care unit patients who need mechanical ventilation Anticipate duration of mechanical ventilation longer than 24 hours,and shorter than 96 hours prior to giving investigational products Acute physiology and chronic health evaluation II score more than 10 Aged between 60 to 80 years old Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight Exclusion Criteria: Trauma and burn patients Any kind of dialysis Suspected or confirmed difficult airway Use of neuromuscular blocking drugs(Except using for intubation ) Neuromuscular disease Epidural or subarachnoid anesthesia Plan to give general anesthesia before 24 hours drugs intervention or after giving investigational drugs Serious central nervous system disease Mental disability or mental disease Acute hepatitis and serious liver disease(Child-Pugh C) Unstable angina and acute myocardium infarction Left ventricular ejection volume less than 30%,heart rate less than 50 beats per minute II and III degree atrioventricular block Systolic pressure less than 90 mmHg after giving vasopressors twice before beginning of this study Consciousness disturbance patients whose blood pressure less than 70mmHg and blood lactate more than 4.0mmol/L Suspected or confirmed long term use of narcotic analgesics Subjects who are breastfeeding or pregnant Allergic to investigational products or with other contraindication Participated in other study within 30 days

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group dexmedetomidine ,dexmedetomidine<br>Continuous pump infusion dexmedetomidine with loading dose of 0.4μg.kg-1 for 10 minutes ,then followed by maintenance dose of 0.2 0.7µg.kg-1 to maintain Sedation-Agitation Scale between 3 and 4. | Drug: Dexmedetomidine<br>* Loading dose:0.4μg.kg-1 Maintenance dose :0.2 0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4.<br>|
| Active Comparator: Group midazolam,midazolam,fentanyl<br>Quickly inject midazolam and fentanyl with loading dose of 0.1mg.kg-1 and 1 μg.kg-1 separately until attaining Sedation-Agitation Scale between 3 and 4,then followed by maintenance dose of 0.05 0.1mg.kg-1.h-1 and fentanyl 0.5 1μg.kg-1.h-1 separately. | Drug: Midazolam<br>* Loading dose of midazolam:0.1mg.kg-1 . Maintenance dose of midazolam :0.05 0.1mg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4<br>Drug: Fentanyl<br>* Loading dose of fentanyl:1 μg.kg-1 . Maintenance dose of fentanyl: 0.5 1μg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure within 48 hours after drug intervention |  | Within 48 hours after drug intervention | 
| Number of Participants with blood pressure decrease more than 20% of the baseline value or systolic pressure less than 100 mmHg |  | within 48 hours afer drug intervention | 
| The number of cases who develop delirium |  | Within 48 hours after drug intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in heart rate |  | Within 48 hours after drug intervention | 
| Changes in respiratory rate |  | Within 48 hours after drug intervention | 
| Changes in central venous pressure |  | Within 48 hours after drug intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation