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Ketamine Prevent POCD (KPPOCD)

Primary Purpose

Necrosis of Femoral Head, Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ketamine
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Necrosis of Femoral Head focused on measuring Postoperative cognitive dysfunction, Ketamine, Surgery

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai Tongji Hospital
  • Renji Hospital, School of Medicine, Shanghai Jiaotong University
  • Shanghai Pudong New Area People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine

Placebo

Arm Description

Ketamine infusion group

Normal saline infusion

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 18, 2014
Last Updated
August 18, 2014
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02220400
Brief Title
Ketamine Prevent POCD
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrosis of Femoral Head, Knee Osteoarthritis
Keywords
Postoperative cognitive dysfunction, Ketamine, Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
484 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
Ketamine infusion group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline infusion
Intervention Type
Drug
Intervention Name(s)
Ketamine
Primary Outcome Measure Information:
Title
Short-term cognitive changes after surgery
Description
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.
Time Frame
The day before surgery and 7 days after surgery (or before leave hospital)
Title
Long-term cognitive changes after surgery
Description
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.
Time Frame
The day before surgery and 2 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoqing Zhang, M.S.
Email
xq_820175@163.com
First Name & Middle Initial & Last Name & Degree
Xiaoqing Zhang, M.S.
Facility Name
Renji Hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
Phone
0086-21-68383702
Email
diansansu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
Facility Name
Shanghai Pudong New Area People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizhi Li, M.S.
Email
Fmlilizhi@sina.com.cn
First Name & Middle Initial & Last Name & Degree
Lizhi Li, M.S.

12. IPD Sharing Statement

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Ketamine Prevent POCD

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