Ketamine Prevent POCD (KPPOCD)

• ClinicalTrials.gov Identifier: NCT02220400
• Recruitment Status: Unknown
• First Posted: August 19, 2014
• Last Update Posted: August 19, 2014
• Sponsor: RenJi Hospital
• Information provided by (Responsible Party): diansan su, RenJi Hospital

Tracking Information

• First Submitted Date: August 18, 2014
• First Posted Date: August 19, 2014
• Last Update Posted Date: August 19, 2014
• Study Start Date: September 2014
• Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine Prevent POCD
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Necrosis of Femoral Head
• Knee Osteoarthritis

• Intervention: Drug: Ketamine

Study Arms

• Experimental: Ketamine
  Ketamine infusion group
  Intervention: Drug: Ketamine
• Placebo Comparator: Placebo
  Normal saline infusion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 18, 2014): 484
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2016
• Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02220400
• Other Study ID Numbers: KPPOCD
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: diansan su, RenJi Hospital
• Study Sponsor: RenJi Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: RenJi Hospital
• Verification Date: August 2014