The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation

Study Overview
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Brief Summary
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This study designed to evaluate the correlation between the effect of intraoperative magnesium sulfate infusion and the incidence of emergence agitation after pediatric ophthalmic surgery

Detailed Description
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Emergence agitation (EA) is a frequent postoperative complication in pediatric patients after general anesthesia. There are several suggested causes of EA and pain has been considered one of them. Magnesium is an N-methyl-D-aspartate (NMDA) receptor antagonist and increasingly used as an analgesic-adjuvant. We evaluate the Pediatric Anesthesia Emergence Delirium (PAED) Scale to investigate whether the intraoperative infusion of magnesium sulfate reduces the incidence of EA in pediatric patients who undergo ophthalmic outpatient surgery.

Official Title
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The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation After Pediatric Ophthalmic Surgery

Conditions
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Agitation,Psychomotor

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pediatric patients who are planned to operate ophthalmic surgery under general anesthesia aged 4-7 years Exclusion Criteria: ASA class ≥ III imbalance of electrolyte myocardial damage or conduction abnormality on ECG myasthenia gravis or any other neuromuscular disease impaired renal function denial to participate in study or not be able to give informed consent

Ages Eligible for Study
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Minimum Age: 4 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline(NS) group<br>loading 50mL of normal saline during 10minutes before starting of surgery, after starting of surgery, continuous infusion of normal saline as placebo by 0.15mg/kg/h until the end of surgery | Drug: Normal saline<br>* Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation<br>* Other names: 0.9% isotonic normal saline;|
| Active Comparator: Magnesium group<br>loading dose of 50mg/kg magnesium sulfate during 10minutes before starting of surgery, during the surgery, continuous infusion of magnesium sulfate by 15mg/kg/h | Drug: Magnesium Sulfate<br>* Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation<br>* Other names: 10% magnesium sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of emergence agitation (EA) | Using PAED (pediatric anesthesia emergence delirium) score, consider the score 10 or more as occuring of EA. Comparing the score between the placebo group and the intervention group for the difference of the incidence of EA. | 15 minute interval at the post-anesthetic care unit (PACU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the severity of EA | Comparing the maximal PAED score between the placebo group and the intervention group for evaluating difference of severity of EA. | 15 minute interval at the post-anesthetic care unit (PACU) |