Ketamine Prevent POCD

Not Applicable

• Conditions: Necrosis of Femoral Head; Knee Osteoarthritis
• Interventions: Drug: Ketamine

• Registration Number: NCT02220400
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-18
• Last Update Submitted: 2014-08-18
• Study First Posted: 2014-08-19
• Last Update Posted: 2014-08-19
• Study Start: 2014-09
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 484

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	Ketamine infusion group

Primary Outcome Measures

Name	Time	Method
Short-term cognitive changes after surgery	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	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.

Trial Locations

Locations (3)

Shanghai Tongji Hospital; 🇨🇳 Shanghai, Shanghai, China

Renji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Pudong New Area People's Hospital; 🇨🇳 Shanghai, Shanghai, China