Magnesium and Postoperative Pain

NCT03253224 | Terminated Phase 4

• 1 other identifier: B-1707/406-006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis Knee; Magnesium Sulfate; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Patient controlled analgesia (PCA)

  Amounts of PCA consumption

  Postoperative 24 hour

Secondary Outcomes (5)

• Numerical rating scale

  Postoperative 24 hour

• Rescue analgesics

  Postoperative 24 hour

• Nausea

  Postoperative 24 hour

• Vomiting

  Postoperative 24 hour

• Antiemetics

  Postoperative 24 hour

Study Arms (2)

Saline

PLACEBO COMPARATOR

Patient who received normal saline during the operation

Drug: Normal saline

Magnesium

EXPERIMENTAL

Patient who received magnesium sulfate during the operation

Drug: Magnesium Sulfate

Interventions

Magnesium Sulfate 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.

Magnesium

Normal saline DRUG

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

Saline

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

MeSH Terms

Interventions

Magnesium Sulfate; Saline Solution

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hyun-Jung Shin, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: September 10, 2017
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: April 18, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)