Magnesium and Postoperative Pain

Sponsor

Seoul National University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03253224

Collaborator

Seoul National University Bundang Hospital (Other)

Enrollment

Location

Arms

6.6

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis Knee Magnesium Sulfate Dexmedetomidine	Drug: Magnesium Sulfate Drug: Normal saline	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Sep 10, 2017

Actual Primary Completion Date :

Mar 29, 2018

Actual Study Completion Date :

Mar 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Saline Patient who received normal saline during the operation	Drug: Normal saline Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.
Experimental: Magnesium Patient who received magnesium sulfate during the operation	Drug: 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.

Arm

Intervention/Treatment

Placebo Comparator: Saline

Patient who received normal saline during the operation

Drug: Normal saline

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

Experimental: Magnesium

Patient who received magnesium sulfate during the operation

Drug: 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.

Outcome Measures

Primary Outcome Measures

Patient controlled analgesia (PCA) [Postoperative 24 hour]
Amounts of PCA consumption

Secondary Outcome Measures

Numerical rating scale [Postoperative 24 hour]
Postoperative pain score
Rescue analgesics [Postoperative 24 hour]
Amounts of the analgesics administered to mange the postoperative pain
Nausea [Postoperative 24 hour]
Incidence of nausea
Vomiting [Postoperative 24 hour]
Incidence of vomiting
Antiemetics [Postoperative 24 hour]
Amounts of antiemetics consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620

Sponsors and Collaborators

Seoul National University Hospital
Seoul National University Bundang Hospital

Investigators

Principal Investigator: Hyun-Jung Shin, MD, PhD, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyun-Jung Shin, Assistant Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT03253224

Other Study ID Numbers:

B-1707/406-006

First Posted:

Aug 17, 2017

Last Update Posted:

Apr 18, 2018

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Magnesium Sulfate

Study Results

No Results Posted as of Apr 18, 2018