Safety of Dexmedetomidine Sedation
Conditions
Keywords
Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation
Brief summary
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.
Interventions
DRUGDexmedetomidine
Loading dose:0.4μg.kg-1 Maintenance dose :0.2\ 0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4.
DRUGMidazolam
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
DRUGFentanyl
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
Sponsors
Fuling Central Hospital of Chongqing City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed