KPPOCD: Ketamine Prevent POCD

Sponsor

RenJi Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02220400

Collaborator

(none)

484

Enrollment

Locations

Arms

Duration (Months)

161.3

Patients Per Site

6.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Ketamine

Ketamine infusion group

Drug: Ketamine

Placebo Comparator: Placebo

Normal saline infusion

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Tongji Hospital	Shanghai	Shanghai	China	200065
2	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai	China	200127
3	Shanghai Pudong New Area People's Hospital	Shanghai	Shanghai	China