Magnesium and Postoperative Pain

NCT ID: NCT03253224

Last Updated: 2018-04-18

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-10

Study Completion Date

2018-03-29

Brief Summary

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With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in particular, has been increasing with the growing demand for improved mobility and quality of life. Total knee arthroplasty is performed on patients with advanced and painful osteoarthritis of the knees, but it can result in moderate to severe postoperative pain during the recovery period.

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.

Detailed Description

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Conditions

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Arthritis Knee Magnesium Sulfate Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline

Patient who received normal saline during the operation

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

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.

Intervention Type DRUG

Normal saline

Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who undergo total knee arthroplasty under spinal anesthesia
* Patients who want to sedation during the surgery
* American Society of Anesthesiologists physical status classification 1 and 2

Exclusion Criteria

* General anesthesia
* Patients who do not want to sedation during the surgery
* Patients who do not receive patient controlled analgesia postoperatively
* Muscular disease
* Hypermagnesemia
* Atrioventricular block
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Jung Shin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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South Korea

Other Identifiers

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B-1707/406-006

Identifier Type: -

Identifier Source: org_study_id

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