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The Effect of Magnesium Sulfate on Motor and Somatosensory Evoked Potentials in Children Undergoing Scoliosis Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Crawford, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01148888
First received: June 21, 2010
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

The primary objective of this study is to determine whether magnesium sulfate has a clinically important effect on the amplitude and latency of somatosensory and motor evoked potentials in patients undergoing surgical correction of idiopathic scoliosis.


Condition Intervention Phase
Scoliosis
Drug: Magnesium
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Magnesium Sulfate on Motor and Somatosensory Evoked Potentials in Children Undergoing Scoliosis Surgery

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Somatosensory and motor evoked potentials [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Cortical SEPs will be measured from Cz-Fpz or Ci-Cc (10-20 system of head measurement) and the amplitudes will be taken from the first positive deflection to first negative deflection (P1-N1) after supramaximal stimulation of the posterior tibial nerves at the medial malleolus. The MEP peak-to-peak amplitudes will be measured from left and right tibialis anterior and abductor hallucis muscles. Stimulation parameters will be varied in order to achieve the maximum amplitude values. Evoked potentials will be measured before and at 10 and 30 minutes after the start of the magnesium infusion.

  • Somatosensory and motor evoked potentials [ Time Frame: 10 and 30 minutes after the start of the magnesium infusion ] [ Designated as safety issue: No ]
    Cortical SEPs will be measured from Cz-Fpz or Ci-Cc (10-20 system of head measurement) and the amplitudes will be taken from the first positive deflection to first negative deflection (P1-N1) after supramaximal stimulation of the posterior tibial nerves at the medial malleolus. The MEP peak-to-peak amplitudes will be measured from left and right tibialis anterior and abductor hallucis muscles. Stimulation parameters will be varied in order to achieve the maximum amplitude values. Evoked potentials will be measured before and at 10 and 30 minutes after the start of the magnesium infusion.


Enrollment: 5
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnesium Sulfate
The study will be conducted in the 45 minute interval between the completion of spinal instrumentation and the completion of skin closure. Once the spinal instrumentation is complete and the integrity of the spinal cord pathways is confirmed using SEPs and MEPs, magnesium will be administered for the remainder of surgery.
Drug: Magnesium
Magnesium will be administered intravenously at a dose of 50 mg/kg bolus followed by an infusion of 10 mg/kg/hr.

Detailed Description:

Motor and somatosensory evoked potentials are continuously monitored in the setting of scoliosis surgery to evaluate the integrity of spinal cord pathways. Detection of neural irritation or injury using motor or somatosensory evoked potentials allows the surgeon to modify technique to reverse the insult and proceed without spinal cord compromise. To facilitate evoked potential monitoring, anesthetic agents that attenuate the evoked responses must be avoided.Several different agents have been studied to try to diminish the acute opioid tolerance and/or hyperalgesia seen with remifentanil.

Two studies investigated the effect of magnesium sulfate on intraoperative remifentanil-induced hyperalgesia. In both studies, post-operative pain scores and opioid consumption were decreased in those patients who received magnesium.

Our aim is to establish that magnesium sulfate does not adversely affect somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) in patients undergoing correction of idiopathic scoliosis. Future clinical trials can then be performed investigating the effect of magnesium sulfate on remifentanil-induced hyperalgesia in the same population.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) status I or II
  • Adolescent children aged 12 to 18 years undergoing surgery for idiopathic scoliosis

Exclusion Criteria:

  • Magnesium use within the last two weeks, either intravenous or oral supplements
  • Patients with known electrolyte imbalances or conduction disorders. (Sodium <135 or >143 mmol/L OR Potassium < 3.7 or > 5.0 mmol/L if 12 to 15 yrs; Potassium <3.7 or >4.8 mmol/L if 16 to 18 yrs)
  • Renal, cardiac or neuromuscular disorders.(Urea < 2.9 or > 7.1 mmol/L OR Creatinine >79 µmol/L if < 13 yrs; Creatinine > 98 µmol/L if >= 14 yrs)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148888

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Mark Crawford, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Mark Crawford, Anesthesiologist-In-Chief, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01148888     History of Changes
Other Study ID Numbers: 1000014574
Study First Received: June 21, 2010
Last Updated: November 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatrics
Anaesthesia
Scoliosis
Magnesium

Additional relevant MeSH terms:
Scoliosis
Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Spinal Diseases
Magnesium Sulfate
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 25, 2014