Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients
Primary Purpose
Safety of Dexmedetomidine Sedation
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Midazolam
Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Safety of Dexmedetomidine Sedation focused on measuring Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group dexmedetomidine ,dexmedetomidine
Group midazolam,midazolam,fentanyl
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in blood pressure 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
The number of cases who develop delirium
Secondary Outcome Measures
Changes in heart rate
Changes in respiratory rate
Changes in central venous pressure
Full Information
NCT ID
NCT02225210
First Posted
August 22, 2014
Last Updated
August 24, 2014
Sponsor
Fuling Central Hospital of Chongqing City
1. Study Identification
Unique Protocol Identification Number
NCT02225210
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fuling Central Hospital of Chongqing City
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety of Dexmedetomidine Sedation
Keywords
Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group dexmedetomidine ,dexmedetomidine
Arm Type
Experimental
Arm Description
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.
Arm Title
Group midazolam,midazolam,fentanyl
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Loading dose:0.4μg.kg-1 Maintenance dose :0.2~0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in blood pressure within 48 hours after drug intervention
Time Frame
Within 48 hours after drug intervention
Title
Number of Participants with blood pressure decrease more than 20% of the baseline value or systolic pressure less than 100 mmHg
Time Frame
within 48 hours afer drug intervention
Title
The number of cases who develop delirium
Time Frame
Within 48 hours after drug intervention
Secondary Outcome Measure Information:
Title
Changes in heart rate
Time Frame
Within 48 hours after drug intervention
Title
Changes in respiratory rate
Time Frame
Within 48 hours after drug intervention
Title
Changes in central venous pressure
Time Frame
Within 48 hours after drug intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
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Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients
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