Ketamine Prevent POCD

NCT ID: NCT02220400

Last Updated: 2014-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Necrosis of Femoral Head Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketamine

Ketamine infusion group

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Placebo

Normal saline infusion

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Ketamine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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diansan su

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Facility Contacts

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Xiaoqing Zhang, M.S.

Role: primary

Diansan Su, Dr.

Role: primary

0086-21-68383702

Lizhi Li, M.S.

Role: primary

Other Identifiers

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KPPOCD

Identifier Type: -

Identifier Source: org_study_id

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