- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02087202
Hyperalgesia and NMDA Receptor Antagonist
March 12, 2014 updated by: Kim Mihyun, Seoul National University Bundang Hospital
NMDA receptor is administered and postoperative remote hyperalgesia is investigated.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA1-2
Exclusion Criteria:
- contraindication to the study drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: magnesium
magnesium is added perioperatively to those patients undergoing staged total knee arthroplasty and other surgeries.
|
magnesium sulfate is added to the patients
|
EXPERIMENTAL: ketamine
ketamine is administered to those patients undergoing stated TKA and other operations.
|
ketamine is added to the patients.
|
PLACEBO_COMPARATOR: control
normal saline (placebo) is administered to the patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain
Time Frame: until 1 month from the end of the operation
|
pain (QST and pain measures )until 1 month from the end of the operation
|
until 1 month from the end of the operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (ANTICIPATED)
July 1, 2014
Study Completion (ANTICIPATED)
July 1, 2014
Study Registration Dates
First Submitted
March 12, 2014
First Submitted That Met QC Criteria
March 12, 2014
First Posted (ESTIMATE)
March 14, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
March 14, 2014
Last Update Submitted That Met QC Criteria
March 12, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Sensation Disorders
- Somatosensory Disorders
- Hyperalgesia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Ketamine
- Magnesium Sulfate
Other Study ID Numbers
- Hyperalgesia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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