Safety of Dexmedetomidine Sedation Clinical Trial
Official title:
Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients -a Single Center,Randomized and Controlled Trial
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.
| Status | Not yet recruiting |
| Enrollment | 80 |
| Est. completion date | July 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 60 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Fuling Central Hospital of Chongqing City |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in blood pressure within 48 hours after drug intervention | Within 48 hours after drug intervention | Yes | |
| Primary | 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 | Yes | |
| Primary | The number of cases who develop delirium | Within 48 hours after drug intervention | Yes | |
| Secondary | Changes in heart rate | Within 48 hours after drug intervention | Yes | |
| Secondary | Changes in respiratory rate | Within 48 hours after drug intervention | Yes | |
| Secondary | Changes in central venous pressure | Within 48 hours after drug intervention | Yes |