The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children

Study Overview
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Brief Summary
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Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children

Detailed Description
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Children < 8 years old who scheduled for elective opthalmic surgery are randomly assigned to Magnesium (Mg) group and control group. Before anesthetic induction, modified Yale Preoperative Anxiety Scale (m-YPAS) is assessed. Routine anesthetic induction is performed, and neuromuscular blocker is not used. Laryngeal mask airway is inserted and controlled ventilation is started. In Mg group, Mg of 30 mg/kg is administered for 10 minutes and then continuously infused (10mg/kg/hr) until 5 minutes before surgery end. In control group, the similar volume of saline is infused. Pediatric Anesthesia Emergence Delirium (PAED) scale and pain score (Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS) will be measured immediately after and 30 minutes after surgery.

Official Title
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The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children

Conditions
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Emergence Delirium

Intervention / Treatment
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* Drug: Magnesium
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged between 2 and 7 years American Society of Anesthesiologist physical status 1 and 2 Children scheduled for opthalmic surgery Exclusion Criteria: Allergy history to any drugs Risk of malignant hyperthermia Neuromuscular disease With arrhythmia Any pulmonary, cardiac, hepatic and renal disease Obesity

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium group<br>Mg is administered with dose of 30 mg/kg for 10 minutes and then 10 mg/kg/hr until 5 minutes before surgery ends | Drug: Magnesium<br>* Mg is administered during anesthesia until 5 minutes before surgery ends<br>* Other names: Magnesium sulfate;|
| Placebo Comparator: Control group<br>Saline is administered with same volume of Mg of magnesium group until 5 minutes before surgery ends | Drug: Saline<br>* Same volume of saline is infused until 5 minutes before surgery ends<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence delirium | Pediatric Anesthesia Emergence Delirium (PAED) scale | 30 minutes after anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS) | At each two points: during emergence in operating room and 30 minutes after surgery ends | 
| Nausea | visual analogue scale | At each two points: during emergence in operating room and 30 minutes after surgery ends | 
| vomiting | number | At each two points: during emergence in operating room and 30 minutes after surgery ends | 
| Duration of post-anesthetic care unit (PACU) stay | Duration of post-anesthetic care unit (PACU) stay | During 1 hour after surgery at PACU |