Clinical Trial: Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Impact of Dexmedetomidine Sedation on the Post-Operative Cognition Dysfunction——a Multiple Center,Randomized, Controlled,Double Blinded Clinical Trial.

Brief Summary:

Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can lead to a reduced ability and seriously affect the quality of life of patients, increase personal and social burden, POCD may also increase mortality.POCD can occur at any age, but the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by preoperative cognitive function and psychological scales postoperative assessment, the main recommendation of the agreed test methods include, Rey auditory verbal test, the connection test, digit span test. In this study, preoperative mini-mental state examination (MMSE) screening, comprehensive neurological function during hospitalization for memory, attention, executive function and exercise capacity test, and telephone follow-up after discharge Scale Revised (TICS-M) test.

Few study showed that dexmedetomidine may improve cognitive function in young patients others show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These results conflict and it is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or not for elderly patients.


Detailed Summary:
Sponsor: The First Affiliated Hospital of Anhui Medical University

Current Primary Outcome:

  • The change of incidence of postoperative cognition dysfunction [ Time Frame: 1 day Before surgery,the 3rd,7th day after the surgery. ]
    1. The neuropsychological tests performed at the day before the surgery, the 3rd and 7th day after the surgery respectively.
    2. A test environment to keep quiet, well-lit, non-interference, all the test items should be completed within 30 min.
    3. Normal population (65 to 90 years age-matched 400 non-surgery people) should perform neuropsychological tests in the same time interval, then calculate the score difference(ΔXc), and the standard deviation(SD) of the difference.
    4. Calculate the difference(ΔX) between the score obtained before surgery and 3 or 7 days after the surgery (there are both positive and negative, we use the absolute value), with this difference( ΔX) divided by the standard deviation（SD）of the difference of the normal population, that is ΔX / SD and it is the Z score.
    5. POCD Diagnosis: if a patient has two or more than two of the absolute value of Z scores ≥1.96, the POCD is exist.
  • The change of incidence of postoperative delirium [ Time Frame: The first, second and third day after the surgery. ]
    Through CAM-ICU to assess the incidence of the postoperative delirium.
  • The change of Neuropsychological status [ Time Frame: the 3rd,6th month after the surgery ]
    Through the Telephone Interview for Cognitive Status-Modified(TICS-m) t

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • The occurrence of cardiovascular events. [ Time Frame: from begging of the anesthesia to the time the patients discharge, up to 1 month. ]
    • The incidence of any adverse or severe adverse events. [ Time Frame: From the beginning of the admitted to 6 month after the surgery, up to 6 month. ]
      Including kidney or brain related adverse events.
    • The variation of heart rate. [ Time Frame: From the beginning to the end of anesthesia,up to 6 hours. ]
      Heart rate is recorded every 15 minutes during the anesthesia.
    • The variation of blood pressure. [ Time Frame: From the beginning to the end of anesthesia,up to 6 hours. ]
      blood pressure is recorded every 15 minutes during the anesthesia.
    • the variation of pulse oxygen saturation. [ Time Frame: From the beginning to the end of anesthesia,up to 6 hours. ]
      Pulse oxygen saturation is recorded every 15 minutes during the anesthesia.
    • The monitor of depth of anesthesia. [ Time Frame: From the beginning to the end of anesthesia,up to 6 hours. ]
      Bispectral index (Bis) is recorded every 15 minutes during the anesthesia.


    Original Secondary Outcome: Same as current

    Information By: The First Affiliated Hospital of Anhui Medical University

    Dates:
    Date Received: October 21, 2014
    Date Started: October 2014
    Date Completion:
    Last Updated: February 21, 2017
    Last Verified: February 2017