Status:
UNKNOWN
Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients
Lead Sponsor:
Fuling Central Hospital of Chongqing City
Conditions:
Safety of Dexmedetomidine Sedation
Eligibility:
All Genders
60-80 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02225210
Start Date
September 1 2014
End Date
July 1 2015
Last Update
August 26 2014
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