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Ketamine Prevent POCD (KPPOCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Necrosis of Femoral Head Knee Osteoarthritis Drug: Ketamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Low Dose Ketamine Prevent the Postoperative Cognitive Dysfunction in Aged Patients Underwent Orthopaedic Surgery,a Randomized Control Double Blinded Multicenter Clinical Trail
Study Start Date : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
Ketamine infusion group
Drug: Ketamine
Placebo Comparator: Placebo
Normal saline infusion



Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220400


Locations
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China, Shanghai
Shanghai Tongji Hospital
Shanghai, Shanghai, China, 200065
Contact: Xiaoqing Zhang, M.S.       xq_820175@163.com   
Principal Investigator: Xiaoqing Zhang, M.S.         
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai, China, 200127
Contact: Diansan Su, Dr.    0086-21-68383702    diansansu@yahoo.com   
Principal Investigator: Diansan Su, Dr.         
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai, China
Contact: Lizhi Li, M.S.       Fmlilizhi@sina.com.cn   
Principal Investigator: Lizhi Li, M.S.         
Sponsors and Collaborators
RenJi Hospital
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Responsible Party: diansan su, Dr., RenJi Hospital
ClinicalTrials.gov Identifier: NCT02220400    
Other Study ID Numbers: KPPOCD
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Keywords provided by diansan su, RenJi Hospital:
Postoperative cognitive dysfunction
Ketamine
Surgery
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Necrosis
Cognitive Dysfunction
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action