Ketamine Prevent POCD

Knee Osteoarthritis Clinical Trial

— KPPOCD  

Official title:

Low Dose Ketamine Prevent the Postoperative Cognitive Dysfunction in Aged Patients Underwent Orthopaedic Surgery，a Randomized Control Double Blinded Multicenter Clinical Trail

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02220400
• Other study ID #: KPPOCD
• Status: Not yet recruiting
• Phase: N/A
• First received: August 18, 2014
• Last updated: August 18, 2014
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2014
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 484
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Necrosis of Femoral Head
• Osteoarthritis, Knee

Intervention

Drug:
• Ketamine

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai
China	Shanghai Pudong New Area People's Hospital	Shanghai	Shanghai
China	Shanghai Tongji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term cognitive changes 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 short-term cognitive changes of patients after surgery.	The day before surgery and 7 days after surgery (or before leave hospital)	No
Primary	Long-term cognitive changes 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.	The day before surgery and 2 months after surgery	No