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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
Fuling Central Hospital of Chongqing City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Safety of Dexmedetomidine Sedation focused on measuring Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 22, 2014
    Last Updated
    August 24, 2014
    Sponsor
    Fuling Central Hospital of Chongqing City
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    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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