Study Results
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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TERMINATED
PHASE4
24 participants
INTERVENTIONAL
2017-09-10
2018-03-29
Brief Summary
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To relieve anxiety or stress during surgery under regional anesthesia, sedation can be provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor agonist, and its analgesic effect has been well established in various procedures or surgeries.
Magnesium has been reported to produce important analgesic effects including the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this study, investigators will evaluate the reducing effect of magnesium on the post-total knee arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Saline
Patient who received normal saline during the operation
Normal saline
Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.
Magnesium
Patient who received magnesium sulfate during the operation
Magnesium Sulfate
Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of normal saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/h) until the end of surgery.
Interventions
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Magnesium Sulfate
Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of normal saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/h) until the end of surgery.
Normal saline
Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.
Eligibility Criteria
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Inclusion Criteria
* Patients who want to sedation during the surgery
* American Society of Anesthesiologists physical status classification 1 and 2
Exclusion Criteria
* Patients who do not want to sedation during the surgery
* Patients who do not receive patient controlled analgesia postoperatively
* Muscular disease
* Hypermagnesemia
* Atrioventricular block
50 Years
75 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Hyun-Jung Shin
Assistant Professor
Principal Investigators
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Hyun-Jung Shin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Countries
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Other Identifiers
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B-1707/406-006
Identifier Type: -
Identifier Source: org_study_id
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