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

Primary Purpose

Scoliosis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Magnesium
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring pediatrics, Anaesthesia, Scoliosis, Magnesium

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnesium Sulfate

Arm Description

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.

Outcomes

Primary Outcome Measures

Somatosensory and motor evoked potentials
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
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.

Secondary Outcome Measures

Full Information

First Posted
June 21, 2010
Last Updated
November 18, 2014
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01148888
Brief Title
The Effect of Magnesium Sulfate on Motor and Somatosensory Evoked Potentials in Children Undergoing Scoliosis Surgery
Official Title
The Effect of Magnesium Sulfate on Motor and Somatosensory Evoked Potentials in Children Undergoing Scoliosis Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
pediatrics, Anaesthesia, Scoliosis, Magnesium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium Sulfate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium
Intervention Description
Magnesium will be administered intravenously at a dose of 50 mg/kg bolus followed by an infusion of 10 mg/kg/hr.
Primary Outcome Measure Information:
Title
Somatosensory and motor evoked potentials
Description
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.
Time Frame
Baseline
Title
Somatosensory and motor evoked potentials
Description
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.
Time Frame
10 and 30 minutes after the start of the magnesium infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Crawford, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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

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