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Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
dexmedetomidine
dexmedetomidine
normal saline
midazolam,fentanyl,etomidate,Cisatracurium besylate
cisatracurium besylate,propofol,remifentanil,sevoflurane
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Cognitive Dysfunction focused on measuring Dexmedetomidine,postoperative cognitive dysfunction

Eligibility Criteria

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

Inclusion Criteria:

  • Written informed consent
  • Elective gastrointestinal surgery
  • American Society of Anesthesiologists class II to III
  • Aged between 65 and 80 years old
  • Weight between 45 and 75 kilogram,Body Mass Index between 19 and 24 kg.m-2
  • With primary hypertension reaching or more than 1 year
  • Normal cognitive function,mini-mental state examination more than 27

Exclusion Criteria:

  • Severe arrhythmia,atrioventricular block and secondary hypertension
  • Liver and kidney dysfunction,pulmonary disease,endocrine disease
  • Suspected or confirmed difficult airway
  • Any disease or pathologic change will interfere study result
  • Inability to exchange with serious visual and hearing impairment
  • Long term use of sedative-hypnotic drugs and antidepressant drug
  • Addicted to alcohol, tobacco or drug
  • Neuromuscular disease
  • Suspected of malignant hyperthermia
  • 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 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Group A, dexmedetomidine , 0.3µg.kg-1.h-1

    Group B,dexmedetomidine , 0.5µg.kg-1.h-1

    Group C ,normal saline

    Arm Description

    Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed Continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation

    Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation

    Normal saline infusion will be given with the same infusion volume as group A and B

    Outcomes

    Primary Outcome Measures

    Change from baseline to postoperation in cognitive function
    Mini-mental State Examination
    Change from baseline to postoperation in recent memory
    Rey Auditory Verbal Learning Test
    Change from baseline to postoperation in visual space and directional force
    Trail Making Test A,Trail Making Test B
    Change from baseline to postoperation in attention
    Digit Span Test
    Change from baseline to postoperation in pain scores
    Visual analog scales
    Change from baseline to postoperation in depression scale
    Beck Depression Inventory

    Secondary Outcome Measures

    The duration of operation
    The blood volume during the operation
    The urine volume during operation
    The dose of drugs used during operation
    The dose of ephedrine, urapidil, atropine used during operation

    Full Information

    First Posted
    August 21, 2014
    Last Updated
    August 21, 2014
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02224443
    Brief Title
    Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients
    Official Title
    Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients-A Single Center,Randomized, Double-blinded,Controlled Study
    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
    August 2015 (Anticipated)
    Study Completion Date
    September 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital Xi'an Jiaotong University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to identify the effects of different doses of dexmedetomidine on postoperative cognitive dysfunction in elderly hypertensive patients

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Cognitive Dysfunction
    Keywords
    Dexmedetomidine,postoperative cognitive dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A, dexmedetomidine , 0.3µg.kg-1.h-1
    Arm Type
    Experimental
    Arm Description
    Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed Continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation
    Arm Title
    Group B,dexmedetomidine , 0.5µg.kg-1.h-1
    Arm Type
    Experimental
    Arm Description
    Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation
    Arm Title
    Group C ,normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    Normal saline infusion will be given with the same infusion volume as group A and B
    Intervention Type
    Drug
    Intervention Name(s)
    dexmedetomidine
    Intervention Description
    Experimental: Group A, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation
    Intervention Type
    Drug
    Intervention Name(s)
    dexmedetomidine
    Intervention Description
    Group B, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Intervention Description
    Group C , Normal saline infusion will be given with the same infusion volume as group A and B
    Intervention Type
    Drug
    Intervention Name(s)
    midazolam,fentanyl,etomidate,Cisatracurium besylate
    Intervention Description
    Anesthesia induction : 0.05 mg.kg-1 midazolam,4~5μg.kg-1 fentanyl,1.0~1.5mg.kg-1etomidate and 0.15 mg.kg-1Cisatracurium besylate
    Intervention Type
    Drug
    Intervention Name(s)
    cisatracurium besylate,propofol,remifentanil,sevoflurane
    Intervention Description
    Maintenance of anesthesia :Continuous pump infusion 0.05~0.1mg.kg-1.h-1cisatracurium besylate,4~8mg.kg-1.h-1propofol,0.1~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%~1.0%
    Primary Outcome Measure Information:
    Title
    Change from baseline to postoperation in cognitive function
    Description
    Mini-mental State Examination
    Time Frame
    One day before operation,third day after operation,sixth day after operaion
    Title
    Change from baseline to postoperation in recent memory
    Description
    Rey Auditory Verbal Learning Test
    Time Frame
    One day before operation,third day after operation,sixth day after operation
    Title
    Change from baseline to postoperation in visual space and directional force
    Description
    Trail Making Test A,Trail Making Test B
    Time Frame
    One day before operation,third day after operation,sixth day after operaion
    Title
    Change from baseline to postoperation in attention
    Description
    Digit Span Test
    Time Frame
    One day before operation,third day after operation,sixth day after operaion
    Title
    Change from baseline to postoperation in pain scores
    Description
    Visual analog scales
    Time Frame
    One day before operation,third day after operation,sixth day after operation
    Title
    Change from baseline to postoperation in depression scale
    Description
    Beck Depression Inventory
    Time Frame
    One day before operation,third day after operation,sixth day after operation
    Secondary Outcome Measure Information:
    Title
    The duration of operation
    Time Frame
    From begining of cutting skin to the end of skin closure,an expected average of 3 hours
    Title
    The blood volume during the operation
    Time Frame
    From begining of cutting skin to the end of skin closure,an expected average of 3 hours
    Title
    The urine volume during operation
    Time Frame
    From begining of cutting skin to the end of skin closure,an expected average of 3 hours
    Title
    The dose of drugs used during operation
    Description
    The dose of ephedrine, urapidil, atropine used during operation
    Time Frame
    From begining of cutting skin to the end of skin closure,an expected average of 3 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written informed consent Elective gastrointestinal surgery American Society of Anesthesiologists class II to III Aged between 65 and 80 years old Weight between 45 and 75 kilogram,Body Mass Index between 19 and 24 kg.m-2 With primary hypertension reaching or more than 1 year Normal cognitive function,mini-mental state examination more than 27 Exclusion Criteria: Severe arrhythmia,atrioventricular block and secondary hypertension Liver and kidney dysfunction,pulmonary disease,endocrine disease Suspected or confirmed difficult airway Any disease or pathologic change will interfere study result Inability to exchange with serious visual and hearing impairment Long term use of sedative-hypnotic drugs and antidepressant drug Addicted to alcohol, tobacco or drug Neuromuscular disease Suspected of malignant hyperthermia 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 Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients

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