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Ketamine Prevent POCD (KPPOCD)

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ClinicalTrials.gov Identifier: NCT02220400
Recruitment Status : Unknown
Verified August 2014 by diansan su, RenJi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
diansan su, RenJi Hospital

Tracking Information
First Submitted Date  ICMJE August 18, 2014
First Posted Date  ICMJE August 19, 2014
Last Update Posted Date August 19, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
  • Short-term cognitive changes after surgery [ Time Frame: The day before surgery and 7 days after surgery (or before leave hospital) ]
    Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol,digit span,color trail test and Stroop color and word test for measuring the short-term cognitive changes of patients after surgery.
  • Long-term cognitive changes after surgery [ Time Frame: The day before surgery and 2 months after surgery ]
    Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol,digit span,color trail test and Stroop color and word test for measuring the long-term cognitive changes of patients after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Prevent POCD
Official Title  ICMJE Low Dose Ketamine Prevent the Postoperative Cognitive Dysfunction in Aged Patients Underwent Orthopaedic Surgery,a Randomized Control Double Blinded Multicenter Clinical Trail
Brief Summary Previous study demonstrated that neuroinflammation induced by surgery is the main cause of the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved to be an anti-inflammation agent. In present study investigators hypothesized that low dose ketamine would prevent the cognition decline after orthopedic surgery in aged patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Necrosis of Femoral Head
  • Knee Osteoarthritis
Intervention  ICMJE Drug: Ketamine
Study Arms  ICMJE
  • Experimental: Ketamine
    Ketamine infusion group
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Normal saline infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 18, 2014)
484
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Elder than 60
  • Easily communicated with Chinese
  • Selected to kneel or hip replacement
  • Agree to take part into this clinical trail

Exclusion Criteria:

  • Existing cerebral disease, or have a history of neurological and psychiatric disease including AD, stroke and psychosis
  • Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
  • Several audition or vision disorder
  • Preoperative systolic Blood pressure over 190mmHg or diastolic pressure >100mmHg
  • Existing a history of hyperthyroidism
  • Patient with glaucoma
  • Unwillingness to comply with the protocol or procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02220400
Other Study ID Numbers  ICMJE KPPOCD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party diansan su, RenJi Hospital
Study Sponsor  ICMJE RenJi Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RenJi Hospital
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP