NCT01148888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

June 21, 2010

Last Update Submit

November 18, 2014

Conditions

Scoliosis

Keywords

pediatricsAnaesthesiaScoliosisMagnesium

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline

  • 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.

    10 and 30 minutes after the start of the magnesium infusion

Study Arms (1)

Magnesium Sulfate

EXPERIMENTAL

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

Interventions

MagnesiumDRUG

Magnesium will be administered intravenously at a dose of 50 mg/kg bolus followed by an infusion of 10 mg/kg/hr.

Magnesium Sulfate

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Mark Crawford, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist-In-Chief

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

CA(1)