NCT02220400

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
484

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

August 18, 2014

Last Update Submit

August 18, 2014

Conditions

Necrosis of Femoral HeadKnee Osteoarthritis

Keywords

Postoperative cognitive dysfunctionKetamineSurgery

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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

Study Arms (2)

Ketamine

EXPERIMENTAL

Ketamine infusion group

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Normal saline infusion

Interventions

KetamineDRUG
Ketamine

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elder than 60
  • Easily communicated with Chinese
  • Selected to kneel or hip replacement
  • Agree to take part into this clinical trail

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

Location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Location

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Osteoarthritis, KneePostoperative Cognitive Complications

Interventions

Ketamine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 19, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 19, 2014

Record last verified: 2014-08

Locations

CN(3)