Role of Magnesium in Pediatric Cochlear Implant

Study Overview
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Brief Summary
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To determine the efficiency of addition of magnesium sulfate to total intravenous anesthesia (TIVA) in optimizing the surgical field during pediatric cochlear implant surgery. Also its effects on the intraoperative evoked stapedial reflex thresholds (ESRT) and the intraoperative anesthetic requirements were evaluated.

Detailed Description
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Sixty-six ASA I and II children (1-6 years) undergoing cochlear implantation under general anesthesia were enrolled in this double blind, randomized study. Children were randomly allocated into two equal groups. Children in Group M (magnesium sulphate group) received an iv bolus dose of magnesium sulfate 40 mg Kg-1 over 5 minutes before induction of anesthesia followed by 15mg Kg-1 h-1 infusion until the start of skin closure. Children in Group C (Control group) received equivalent volumes of isotonic saline solution over the same period instead of magnesium sulphate. Haemodynamic variables, quality of surgical field, ESRT and the intraoperative anesthetic requirements were recorded

Official Title
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Combination of Magnesium Sulphate With Total Intravenous Anesthesia Optimized Surgical Field in Pediatric Cochlear Implant Surgery

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Magnesium sulphate
* Other: Na CL 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I and II children Exclusion Criteria: uncontrolled hypertension, diabetes mellitus, liver disease, kidney disease, heart disease, allergy to magnesium sulphate,
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium sulphate<br>Group M | Drug: Magnesium sulphate<br>* Before induction of anesthesia; children in group M received an iv bolus dose of magnesium sulfate (Magnesium sulfate ampoule 1 gm/10 ml, Eipico, Egypt) 40 mg Kg-1 over 5 minutes followed by 15 mg Kg-1 h-1 ivi until the start of skin closure.<br>* Other names: MGSO4;|
| Placebo Comparator: Na CL 0.9%<br>group C | Other: Na CL 0.9%<br>* Before induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of magnesium sulphate.<br>* Other names: isotonic saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of surgical field | using Fromme's-Boezaart scale (0 to 5). A score of ≤ 2 was considered to be optimal | at the end of the surgey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The operative time | Minutes | Intraoperative | 
| The anesthesia time. | Minutes | Intraoperative | 
| ESRT responses | the surgeon assessed ESRT response at the basal, middle, and apical areas of the electrode array by visual monitoring of the stapedius muscle using direct microscopic examination | After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9), | 
| Heart rate | beats per minute | baseline, after surgical incision, Hypotensive period, after LMA removal and at recovery room admission. | 
| Mean arterial blood pressure | mm Hg | Intraoperative | 
| Anesthetic consumption | propofol and fentanyl requirement after the bolus | Intraoperative |