Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation

Study Overview
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Brief Summary
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to study the effect of oral gabapentin (5 mg/kg) on emergence agitation after desflurane anesthesia in pediatrics undergoing starbismus surgery

Official Title
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The Role of Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation and Delirium in Children After Strabismus Surgery: A Prospective Randomized Double-blind Study

Conditions
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Emergence Agitation After Desflurane Anesthesia

Intervention / Treatment
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* Drug: Strawberry juice as (placebo)
* Drug: Gabapentin Oral Solution [Neurontin]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pediatric patients (2-6 years old), with an American society of Anesthegiologists physical status (ASA) I-II who were undergoing strabismus surgery (for more than one muscle) Exclusion Criteria: failure to obtain consent, mental retardation or developmental delay, epilepsy, psychiatric or neurological diseases that impair communication, current use of gabapentin, psychotropic or opioids.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>patients received strawberry juice 5 ml volume, one hour before induction. | Drug: Strawberry juice as (placebo)<br>* Patients received strawberry juice 5 ml volume, one hour before induction.<br>* Other names: Strawberry juice;|
| Active Comparator: Gabapentin group<br>patients received gabapentin (Neurontin oral solution 250 mg/ml, Pfizer, USA) 5 mg/kg mixed with strawberry juice to constitute 5 ml volume, one hour before induction. | Drug: Gabapentin Oral Solution [Neurontin]<br>* Patients received gabapentin (Neurontin oral solution 250 mg/ml, Pfizer, USA) 5 mg/kg mixed with strawberry juice to constitute 5 ml volume, one hour before induction.<br>* Other names: Neurontin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergence agitation incidence and scores | agitation measured by emergence agitation scale: [1= Obtunded with no response to stimuli; 2= Asleep, but responsive to movement and stimuli; 3= Awake and appropriately responsive; and 4= Crying and difficult to console; 5= Wild thrashing behaviour that requires restraint]. A score 4 or 5 was considered as agitation and was treated by IV meperidine 0.5 -1 mg/kg increments. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of emergence | The time from the discontinuation of anesthesia till the time of spontaneous eye opening or to verbal command | through study completion, an average of 1 year |