Magnesium and Postoperative Pain
Primary Purpose
Arthritis Knee, Magnesium Sulfate, Dexmedetomidine
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium Sulfate
Normal saline
Sponsored by

About this trial
This is an interventional supportive care trial for Arthritis Knee
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Saline
Magnesium
Arm Description
Patient who received normal saline during the operation
Patient who received magnesium sulfate during the operation
Outcomes
Primary Outcome Measures
Patient controlled analgesia (PCA)
Amounts of PCA consumption
Secondary Outcome Measures
Numerical rating scale
Postoperative pain score
Rescue analgesics
Amounts of the analgesics administered to mange the postoperative pain
Nausea
Incidence of nausea
Vomiting
Incidence of vomiting
Antiemetics
Amounts of antiemetics consumption
Full Information
NCT ID
NCT03253224
First Posted
August 15, 2017
Last Updated
April 16, 2018
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03253224
Brief Title
Magnesium and Postoperative Pain
Official Title
The Influence of Intraoperative Magnesium Sulfate Administration on Postoperative Pain After Total Knee Arthroplasty in Patients Sedated With Dexmedetomidine Under Spinal Anesthesia: A Randomized-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Because the principle investigator will participate a visiting scholar program for one year in other country, this study has been terminated.
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
March 29, 2018 (Actual)
Study Completion Date
March 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Knee, Magnesium Sulfate, Dexmedetomidine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Patient who received normal saline during the operation
Arm Title
Magnesium
Arm Type
Experimental
Arm Description
Patient who received magnesium sulfate during the operation
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
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
Intervention Name(s)
Normal saline
Intervention Description
Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.
Primary Outcome Measure Information:
Title
Patient controlled analgesia (PCA)
Description
Amounts of PCA consumption
Time Frame
Postoperative 24 hour
Secondary Outcome Measure Information:
Title
Numerical rating scale
Description
Postoperative pain score
Time Frame
Postoperative 24 hour
Title
Rescue analgesics
Description
Amounts of the analgesics administered to mange the postoperative pain
Time Frame
Postoperative 24 hour
Title
Nausea
Description
Incidence of nausea
Time Frame
Postoperative 24 hour
Title
Vomiting
Description
Incidence of vomiting
Time Frame
Postoperative 24 hour
Title
Antiemetics
Description
Amounts of antiemetics consumption
Time Frame
Postoperative 24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Jung Shin, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Magnesium and Postoperative Pain
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