Clinical trial NCT02225210: Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients
Official title: Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients -a Single Center,Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Safety of Dexmedetomidine Sedation
Keywords: Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation
Lead sponsor: Fuling Central Hospital of Chongqing City
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Changes in blood pressure within 48 hours after drug intervention
timeFrame: Within 48 hours after drug intervention
measure: Number of Participants with blood pressure decrease more than 20% of the baseline value or systolic pressure less than 100 mmHg
timeFrame: within 48 hours afer drug intervention
measure: The number of cases who develop delirium
timeFrame: Within 48 hours after drug intervention
Secondary outcomes:
measure: Changes in heart rate
timeFrame: Within 48 hours after drug intervention
measure: Changes in respiratory rate
timeFrame: Within 48 hours after drug intervention
measure: Changes in central venous pressure
timeFrame: Within 48 hours after drug intervention
Other outcomes:
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