Hyperalgesia and NMDA Receptor Antagonist | NCT02087202

Studies
Hyperalgesia and NMDA Receptor Antagonist

NCT02087202

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Mar 14, 2014Estimated

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Magnesium Sulfate
ketamine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jul 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Mar 12, 2014

First Submission Date that Met QC Criteria

Mar 12, 2014

First Posted Date

Mar 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2014

Last Update Posted Date

Mar 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kim Mihyun, clinical professor, Seoul St. Mary's HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

NMDA receptor is administered and postoperative remote hyperalgesia is investigated.

Detailed Description

NMDA receptor is adminstered and postoperative tertiary hyperalgesia is investigated.

QST and pain measures for remote hyperalgesia are compared between control and magnesium or ketamine group.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
magnesium	Experimental	magnesium is added perioperatively to those patients undergoing staged total knee arthroplasty and other surgeries.	Drug: Magnesium Sulfate
ketamine	Experimental	ketamine is administered to those patients undergoing stated TKA and other operations.	Drug: ketamine
control	Placebo Comparator	normal saline (placebo) is administered to the patients.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Sulfate	Drug	magnesium sulfate is added to the patients	magnesium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain	pain (QST and pain measures )until 1 month from the end of the operation	until 1 month from the end of the operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA1-2

Exclusion Criteria:

contraindication to the study drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008278	Magnesium Sulfate
D007649	Ketamine

Ancestor Terms

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids

Browse Leaves

Not provided

Browse Branches

Not provided