Addition of Magnesium Sulfate to Caudal to Prevent Postoperative Emergence Agitation.

Study Overview
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Brief Summary
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Emergence agitation after sevoflurane anesthesia is still a problem needed to be solved.The aim of the study is to delineate the effect of caudal magnesium sulfate in children undergoing lower abdominal surgery to prevent postoperative emergence agitation.

Detailed Description
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Emergency agitation is considered one of the postoperative complication after sevoflurane anesthesia.In the enrollment of this study,children undergoing lower abdominal surgery will be enrolled in one of two groups.BM group, receive caudal magnesium sulfate 50 mg beside the conventional bupivacaine in the caudal space in ,B group, addition of 1 ml of normal saline0.9% to bupivacine .Monitoring of the postoperative emergence agitation by different emergence agitation scores with monitoring of sedation score.Detection of expected postoperative complications as nausea and vomiting.

Official Title
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Addition of Magnesium Sulfate to Caudal for Prevention of Emergence Agitation in Children

Conditions
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Agitation, Pediatric Disorder

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: 0.9%normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children undergoing lower abdominal surgery for hernia repair/orchiopexy in Ain Shams University ASA physical status I under sevoflurane anesthesia. age from 1-6 years. Exclusion Criteria: children with developmental delay neurological disorder. psychological disorder difficult airway hyperactive airway disease contraindication to caudal block(sacral abnormality,bleeding disorder).

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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 sulfate<br>magnesium sulfate 50mg caudal 1ml(5%) prepared after addition of 9ml of 0.9%normal saline to 1ml of 500mg(50%)of magnesium sulfate to be added to 1ml/kg of 0.25%of bupivacaine in caudal block in children undergoing lower abdominal surgery under sevoflurane anesthesia to prevent emergence agitation. | Drug: Magnesium Sulfate<br>* use of 50mg magnesium sulfate in caudal analgesia added to 1ml/kg of 0.25% of bupivacaine in children undergoing lower abdominal surgery for prevention of postoperative emergence agitation.<br>|
| Placebo Comparator: o.9%normal saline<br>0.9% of normal saline added to the conventional 0.25% bupivacaine in caudal block. | Drug: 0.9%normal saline<br>* use of 1ml of 0.9%normal saline added to 1ml/kg of 0.25% of bupivacaine in the caudal block as placebo to compare with active comparator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of postoperative pediatric anesthesia emergence delirium PAED score | measurement of PAED score every 5 minutes in the first 30 minutes after lower abdominal surgery in children 1-6 year age after sevoflurane anesthesia. | first 30 minutes postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of postoperative sedation score. | use of sedation score as a measure of postoperative sedation expected after caudal magnesium sulfate every 5 minutes for 30 minutes after end of surgery. | the first 30 minutes postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sevoflurane, pediatric, lower abdominal surgery, caudal, magnesium sulfate, Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, Agitation States as Acute Reaction to Exceptional Stress